Welcome to Fierce Pharma's regulatory tracker for the second half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Be sure to come back regularly for the latest updates.
UPDATED: Wednesday, Aug. 12 at 9:13 a.m. ET
Akeso has scored a key approval in China for its PD-1xVEGF bispecific, ivonescimab, in combination with chemotherapy, for the treatment of first-line squamous non-small cell lung cancer (NSCLC).
The go-ahead is based on results from the phase 3 Harmoni-6 study, in which ivonescimab plus chemo significantly reduced patients' risk of death by 34% compared with BeOne Medicines' Tevimbra and chemo. Median overall survival was 27.9 months in the ivonescimab arm versus 23.7 months in the control arm. The study marked the first time that a regimen beat the standard PD-1-plus-chemo cocktail in a first-line NSCLC setting in a randomized phase 3 study.
"We are incredibly pleased by the approval of ivonescimab plus chemotherapy for first-line advanced squamous NSCLC. This approval marks a critical milestone in the development of next-generation immuno-oncology therapies worldwide," Akeso CEO Xia Yu, Ph.D., said in an Aug. 12 statement.
Meanwhile, the oncology field is awaiting progression-free survival results this year from the squamous cohort of Akeso partner Summit Therapeutics' Harmoni-3 study, a global phase 3 pitting ivonescimab against Merck & Co.'s Keytruda, both in combination with chemo, in first-line NSCLC. Previously, an interim analysis surprised by missing statistical significance.
The PD-1xVEGF field has heated up since ivonescimab's head-to-head success against Keytruda in the Harmoni-2 study in Chinese patients with previously untreated PD-L1-positive NSCLC. Also in first-line squamous NSCLC, AbbVie just registered a global phase 3 study for its PD-1xVEGF candidate, ABBV-1480, licensed from China's RemeGen earlier this year for $650 million up front.
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Eli Lilly's Foundayo for weight management and Type 2 diabetes, making the country the first in Europe to approve the oral GLP-1 drug.
Following Monday's approval, Lilly still needs to go through cost-effectiveness analysis by the National Institute for Health and Care Excellence (NICE) to win coverage through the country’s National Health Service.
China’s National Medical Products Administration also approved (PDF) AstraZeneca and Daiichi Sankyo's HER2 antibody-drug conjugate, Enhertu, used alongside Roche's Perjeta, as a first-line treatment for HER2-positive breast cancer.
In the Destiny-Breast09 trial, Enhertu and Perjeta reduced the risk of disease progression or death by 44% versus the traditional THP regimen of taxane, Herceptin and Perjeta. The study enrolled patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant therapy more than six months before the diagnosis of advanced or metastatic disease.
“This approval marks a major milestone for patients with HER2 positive metastatic breast cancer in China as it brings Enhertu into the first-line treatment setting, which has the potential to improve long-term outcomes for patients,” Daiichi's China president, Michio Hayashi, said in an Aug. 12 statement. “In less than a year, Enhertu has been approved for four new indications in China, underscoring our commitment to bring this transformative medicine to patients.”
UPDATED: Friday, Aug. 7 at 10:45 a.m. ET
Nanjing’s TransThera Sciences has passed a key oncology milestone in China, securing an approval in its home country to tackle FGFR inhibitor therapy resistance in bile duct cancer patients.
On Thursday, China’s National Medical Products Administration (NMPA) signed off on TransThera’s tinengotinib—now christened Yochanra—in adults with advanced, metastatic or unresectable cholangiocarcinoma with an FGFR2 fusion or rearrangement. Critically, patients must have previously received systemic therapy and FGFR inhibitor therapy to qualify for TransThera’s multi-target kinase inhibitor.
According to the company, Yochanra is the first medicine developed independently in China to tackle acquired FGFR inhibitor resistance in bile duct cancer. The asset has also received a fast track tag and orphan drug designation at the FDA, plus orphan drug status with the European Medicines Agency, TransThera said.
TransThera hopes the NMPA approval is just the first of many under its multi-indication development strategy.
As for Yochanra’s present niche, more than 25% of patients with cholangiocarcinoma harbor FGFR mutations, while research has suggested that patients with this form of cancer often develop resistance to FGFR inhibition. Moreover, people who develop resistance often have at least one, and often multiple, mutations, which creates “extremely high barriers to drug development in this field,” per TransThera.
Drugs in the indication that fall under the FGFR inhibitor umbrella include Incyte’s Pemazyre (pemigatinib) and Taiho Oncology’s Lytgobi (futibatinib).
The NMPA cleared the way for Yochanra’s debut after reviewing results from an open-label, pivotal phase 2 trial run in China, which TransThera previously presented at the 2026 ASCO annual meeting in Chicago.
Assessments of that trial tethered Yochanra to an objective response rate of 28%, with 14 patients achieving a confirmed partial response. The trial enrolled a total of 50 patients with advanced cholangiocarcinoma.
Median progression-free survival for Yochanra landed at 6 months, while median overall survival reached 20.7 months, TransThera said in its release this week.
The company noted Thursday that estimates have placed the global market for cholangiocarcinoma therapeutics at $3.2 billion by 2027, up from $2 billion in 2024.
UPDATED: Thursday, July 30 at 3:15 p.m. ET
On the same day that the European Union endorsed AbbVie’s JAK inhibitor Rinvoq as a treatment for alopecia areata (AA), it tacked on another nod for the blockbuster in non-segmental vitiligo (NSV). Both approvals cover patients age 12 and older.
Rinvoq becomes the first systemic therapy in Europe for NSV, a chronic autoimmune disease that causes the immune system to attack cells that make melanin, leading to white patches of skin. NSV accounts for 84% of the cases of vitiligo.
Competition could come shortly for AbbVie, however, as Pfizer has reported successful results from a phase 3 trial of its JAK inhibitor Litfulo and said that it plans to submit the oral med for approval in the indication. Additionally, Incyte’s JAK inhibitor topical cream Opzelura is also approved in Europe for NSV.
The FDA has yet to endorse Rinvoq in either AA or NSV. The company filed for approval in Europe and the U.S. in February. Rinvoq delivered sales of $8.3 billion in 2025, its sixth full year on the market.
UPDATED: Wednesday, July 29 at 2:50 p.m. ET
In its quest to scoop up yet another immunology indication for its JAK inhibitor Rinvoq, AbbVie has broken through to treatment of severe alopecia areata.
The med’s world-first approval in the hair follicle-attacking autoimmune disease has come by way of Europe, where AbbVie announced Wednesday that the European Commission signed off on Rinvoq to treat both adults and adolescents ages 12 years and up.
Rinvoq is still being assessed in alopecia by the FDA after AbbVie submitted its U.S. approval filing in late April.
The European Commission made its call after reviewing phase 3 data from AbbVie’s ongoing UP-AA clinical program. Last August, AbbVie unveiled a series of eye-popping results in alopecia from parallel studies that met their primary endpoint when more than half of patients on the highest Rinvoq dose achieved 80% or more scalp hair coverage at 24 weeks.
Alopecia areata is an autoimmune disease that attacks the body’s hair follicles, leading to patchy hair loss that can range from sudden, round bald patches on the scalp, to complete body hair loss.
Also in Europe, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has tendered a positive opinion on Amgen’s Repatha to reduce cardiovascular risk by lowering cholesterol levels in adults who are at high risk for or have established atherosclerotic cardiovascular disease, as an adjunct to correction of other risk factors.
With the CHMP’s thumbs-up, a final European Commission decision in the new indication is expected “in the coming months,” Amgen noted in a release.
The positive opinion on Repatha—Amgen’s heart and cholesterol blockbuster that was first cleared by the FDA in 2015—hinges on results from Amgen’s late-stage Vesalius-CV trial, which showed that Repatha on top of statins or other LDL-C-lowering treatments significantly curbed patients’ risk of major adverse cardiovascular events (MACE).
Across the pond, Viatris has scored an FDA nod for its combined hormonal contraceptive patch with low-dose estrogen, which will now be marketed as Gwyn Lo.
The dosage for the product covers 220 mcg/day of the synthetic progestin norelgestromin and 20 mcg/day of the estrogen ethinyl estradiol.
Viatris noted that the patch has demonstrated contraceptive efficacy for women with a body mass index (BMI) below 30 kg/m², whom it described as “appropriate candidates” for combined hormonal contraception.
"Gwyn Lo will provide a discreet option for women seeking a reversible, non-invasive, once-weekly contraception patch with a low dose of estrogen," Viatris’ R&D chief Philippe Martin said in a statement Wednesday.
Viatris scored approval via the FDA's 505(b)(2) regulatory pathway, which can help modified versions of previously approved drugs make it to market faster by leaning in part on pre-existing safety and efficacy data. The company also girded its filing with results from a phase 3 study dubbed Luminous.
Viatris expects Gwyn Lo to hit the market later this year.
UPDATED: Tuesday, July 28 at 10:20 a.m. ET
The FDA has signed off on MannKind’s Furoscix ReadyFlow (furosemide) autoinjector for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD).
Furoscix ReadyFlow becomes the first at-home treatment option to reduce the fluid buildup from HF or CKD. The drug-device combo has been designed to help patients address edema earlier, before symptoms worsen and lead to potential emergency department visits or hospitalization. It has been shown to work as effectively as an intravenous diuretic, which is usually administered in a clinic or hospital.
Furoscix ReadyFlow is taken under the skin in less than 10 seconds, significantly reducing the administration time from five hours with MannKind’s currently available on-body infusor. The company expects to make Furoscix available in the U.S. by the end of August.
The FDA nod is backed by data showing Furoscix ReadyFlow achieved its primary pharmacokinetic endpoint and demonstrated equivalent urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours compared to IV furosemide.
It is the second FDA approval for MannKind in a span of two months. In late May, the California-based company scored an expansion for its inhaled insulin powder Afrezza, making it available to children as young as age 6 who have Type 1 or Type 2 diabetes.
Johnson & Johnson consumer health spinoff Kenvue has also secured an FDA nod, in its case landing a key approval in the realm of over-the-counter pain relief.
Late last week, the U.S. regulator signed off on the first OTC, fixed-dose combination of Tylenol (acetaminophen) and naproxen sodium, a non-steroidal anti-inflammatory, which Kenvue says offers a significant expansion in non-opioid options for addressing persistent pain.
The approved combination includes 650 mg of acetaminophen with the “long-lasting analgesic power” of 220-mg naproxen sodium, designed to start working in less than half an hour and provide relief for half of an entire day, per the company. With the green light, branded Tylenol has also won a three-year period of exclusivity for the new OTC formulation, Kenvue added.
The FDA’s decision was informed by data from eight clinical trials, in which the new combination topped Tylenol or naproxen sodium alone on pain relief, showed quick onset of action and kept that relief going for 12 hours through a single dose.
Kenvue argues that patients have been clamoring for a better over-the-counter pain relief option, citing its own consumer survey that found an estimated 75% of persistent pain sufferers were unsatisfied with the current treatments available to them.
Across the pond, the European Medicines Agency rounded out the prior week with a slate of approval recommendations, expansion blessings and a handful of negative determinations, which must now go before the European Commission for final sign-off.
Headlining the roundup were three marketing authorization recommendations for new medications to treat hypercholesterolemia or mixed dyslipidemia, both conditions that lead to high levels of cholesterol in the blood. The recommendations were awarded to LIB Therapeutics’ self-administered injection Lyrokaul (lerodalcibep), plus daily orals Evlarco (obicetrapib/ezetimibe) and Ubeslo (obicetrapib), both from Menarini.
Other notable drugs to win the blessing of the EMA’s Committee for Medicinal Products for Human Use (CHMP) last week include Roche’s Susvimo (rabinizumab), which has received a recommendation in wet age-related macular degeneration; Johnson & Johnson’s Icotyde in moderate-to-severe plaque psoriasis in adults and adolescents; and GSK’s Lynavoy to treat cholestatic pruritus, a complication of the autoimmune disease primary biliary cholangitis that is defined by intense itchiness.
Meanwhile, three drugs failed to pass muster in the eyes of the CHMP, which has tendered negative marketing authorization opinions on Proveca Pharma’s sufentanil-ketamine combo for childhood pain KemSu, Zevra’s Meplyffa in the rare, inherited neurodegenerative disorder Niemann-Pick disease type C, and CATS Consultants’ Qezzaqar, which has been angling for a green light in two types of soft tissue sarcomas.
Zevra secured an FDA nod for its medicine in the U.S., where it’s christened Miplyffa, to treat Niemann-Pick disease type C in conjunction with J&J’s enzyme inhibitor miglustat in the fall of 2024.
UPDATED: Thursday, July 23 at 10:20 a.m. ET
While AstraZeneca awaits a decision in the United States on its breast cancer drug camizestrant, it has received clearance closer to home as the European Union has granted marketing authorization to the selective estrogen receptor degrader (SERD).
Camizestrant will be known commercially as Etcamah, to be used in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor to treat adults with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of an ESR1 mutation and without disease progression during first-line endocrine therapy.
Other CDK 4/6 inhibitors include Eli Lilly’s Verzenio, Novartis’ Kisqali and Pfizer’s Ibrance.
The nod was based on a phase 3 switching study which showed that the Etcamah combo reduced the risk of disease progression or death by 56% versus standard-of-care treatment, which includes an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor. After detecting an ESR1 mutation, investigators swapped the AI for camizestrant. AZ linked switching to its SERD with the 56% jump in progression-free survival.
In May, the FDA delayed a decision on camizestrant to review analyses filed after an advisory committee voted against its approval by a 6-3 margin. During the adcomm, the FDA raised questions about the study design and doubts that camizestrant provides a clinically meaningful benefit.
Takeda has secured approval from China’s National Medical Products Administration (NMPA) for Orzeyful (oveporexton) for the treatment of narcolepsy type 1 (NT1) in those ages 16 and older.
Orzeyful becomes the first medicine approved in China for NT1, as well as the first treatment OK'd in the country in its oral orexin receptor 2-selective agonist drug class.
Narcolepsy impacts an estimated 700,000 people in China, with NT1 accounting for up to 80% of cases, Takeda said. Treatment options in China have been limited to “symptomatic therapies to manage individual symptoms,” Han Fang, the director of the Sleep Medicine Center at Peking University People’s Hospital, said in a release.
The approval is based on two phase 3 studies that showed statistically significant improvements versus placebo across the NT1 symptoms assessed. This included improvements in excessive daytime sleepiness, cataplexy and other secondary measures.
Orzeyful is under review in Japan and in the U.S., where it faces a Sept. 30 decision date.
UPDATED: Monday, July 20 at 9:35 a.m. ET
With a blessing to head to market from the Drug Controller General of India (DCGI), Takeda’s Qdenga has become the first vaccine approved in the country to protect against the viral infection dengue, which is spread by way of mosquito bites.
The green light covers the four dengue virus serotypes and can be used in kids and adults between the ages of 4 and 60 years, Reuters and other local publications reported early Monday.
In a late-stage study, Qdenga, which has now secured clearance in dozens of countries around the world, was tied to efficacy of a little over 80% against confirmed dengue cases one year after participants received their second dose, Reuters noted.
After years of development work on Qdenga, Takeda garnered its first global approval with a green light in Indonesia back in the summer of 2022.
The vaccine is based on a live-attenuated dengue serotype 2 virus that Takeda says it’s designed to serve as a genetic backbone for all four virus serotypes.
While Takeda originally had hopes for Qdenga on the U.S. travel vaccine market, the company reworked its plans around mid-2023, withdrawing its application at the FDA after the regulator sought additional data not captured by the drugmaker’s late-stage TIDES trial.
The vaccine has also scored regulatory nods in Europe, the United Kingdom, Brazil and Argentina, alongside other Asian countries such as Thailand, to name a few.
In India specifically, Takeda in early 2024 linked up with local drugmaker Biological E for manufacturing help to expand access to Qdenga multi-dose vials in endemic countries by the end of the decade.
In the United Kingdom, the country’s drug value watchdog, the National Institute for Health and Care Excellence (NICE), has teed up Bayer’s heart failure med Kerendia (finerenone) for use through the country’s National Health Service (NHS).
In final draft guidance issued last week, NICE recommended (PDF) Bayer’s non-steroid drug as a treatment through the country’s healthcare system for adult patients with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.
In justifying its call, NICE said clinical data points to the fact that Kerendia can curb the risk of heart-failure events that require urgent hospital visits or hospitalizations versus placebo. The drug may also reduce the risk of death from cardiovascular or other causes, but the evidence on that front remains “uncertain,” per NICE.
The value watchdog’s cost-effectiveness calculus has helped it determine that Kerendia’s use in heart failure is an “acceptable use of NHS resources,” NICE said.
Bayer scored a U.S. nod for Kerendia in heart failure with either preserved or mildly reduced ejection fraction last July. That green light came after the mineralocorticoid receptor antagonist’s inaugural FDA approval some four years prior to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease (CKD) associated with type 2 diabetes.
UPDATED: Friday, July 17 at 11:20 a.m. ET
Boehringer Ingelheim has secured a thumbs up from the European Commission clearing its preferential PDE4B inhibitor as a treatment for adults with idiopathic pulmonary fibrosis (IPF) and those with progressive pulmonary fibrosis (PPF).
The EC’s sign-off makes the approval official after Jascayd (nerandomilast) received the blessing of Europe’s CHMP in May.
European regulators cleared the drug on data from the late-stage Fibroneer program, as part of which both Boehringer’s Fibroneer-IPF and Fibroneer-ILD studies met their primary endpoints through Jascayd’s successful slowing of lung function decline from baseline to one year versus placebo.
The key secondary endpoint wasn’t met in either trial, but Boehringer Ingelheim pointed to a numerical reduction in mortality observed in both studies.
IPF and PPF are estimated to affect more than 500,000 people across Europe, leading to irreversible lung scarring that significantly impairs breathing.
The FDA approved Jascayd in IPF in October before the drug quickly expanded into PFF in the U.S. in December.
Meanwhile, shortly after securing a thumbs up for its Wegovy pill in Europe, Novo Nordisk’s injectable obesity med has expanded into fatty liver disease in India.
On Friday, India’s drug regulator, the Central Drugs Standard Control Organisation, approved the 2.4 mg dose of injectable semaglutide to treat metabolic dysfunction-associated steatohepatitis (MASH), Reuters and multiple Indian news outlets reported.
The approval was based on data from the Essence trial, in which injectable Wegovy helped resolve steatohepatitis in 63% of patients and achieve reduction in liver fibrosis in 37% of patients, versus 34% and 23% of patients on placebo, respectively.
Novo’s semaglutide empire added another achievement this week with a green light for its Wegovy pill from the European Commission on Thursday. The approval gives Novo a head start in the bloc, where regulators are still reviewing the application for Eli Lilly’s rival obesity pill Foundayo.
UPDATED: Tuesday, July 14 at 10:40 a.m. ET
- A little over a year after snagging an FDA green light for an autoinjector maintenance dose of their Alzheimer’s disease med Leqembi (lecanemab), partners Biogen and Eisai have received the FDA all-clear for their subcutaneous formulation to initiate treatment.
The nod goes to the partners’ Leqembi Iqlik device and covers a 500 mg Leqembi regimen given once a week as two 250 mg injections, according to a July 14 press release (PDF).
Patients can now spend their entire treatment journey on Leqembi using the subcutaneous format, rather than the IV version that was initially approved and, until now, was still required for initiation doses.
The approval was supported by multiple sub-studies within Leqembi’s phase 3 Clarity AD-long-term extension trial. Collectively, that data showed that once-weekly subQ Leqembi supported similar efficacy and amyloid removal compared to the intravenous format, and that exposure-related adverse events like ARIA-E were on par between the subQ and IV administration routes.
Biogen and Eisai noted that the overall safety of Leqembi Iqlik is “generally similar” to the intravenous formulation.
Leqembi has been slower to build out its market presence than analysts initially expected. But as things have slowly ramped up, Eisai said in May that it now expects sales of the product to circle $900 million this year, just shy of the blockbuster sales threshold.
“It is premature to speculate on potential revenue for SC initiation therapy, however, we do see this approval as a competitive advantage,” an Eisai spokesperson told Fierce Pharma in a statement Tuesday. “With the rapid growth of Leqembi, it is challenging to estimate potential patient numbers. The data Eisai has access to does not directly reflect the number of patients who will use Iqlik.”
Elsewhere, the European Commission has handed a formal update for Erbitux’s label in the EU to Germany’s Merck KGaA, which controls marketing of the Eli Lilly cancer med in the bloc.
Specifically, the therapy is now indicated in combination with Pfizer’s Braftovi (encorafenib) for patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC), both as a first-line treatment in combination with the FOLFOX chemotherapy regimen and for those who’ve received prior treatment with a systemic therapy, per a July 14 release.
The first-line nod was buoyed by results from the late-stage Breakwater trial, in which the triple combo of Erbitux, Braftovi and FOLFOX delivered statistically significant and clinically meaningful improvements on dual primary endpoints of objective response rate and progression-free survival, according to Merck KGaA.
UPDATED: Monday, July 13 at 3:00 p.m. ET
Nine months after the FDA rejected Sydnexis’ application for approval of its low-dose atropine treatment for pediatric progressive myopia (PPM), the U.S. regulator is calling an advisory committee meeting to reconsider the submission, with a date for the panel yet to be determined.
In its complete response letter, the FDA acknowledged that a phase 3 trial of SYD-101, which included more than 800 children ages 3-14, met its primary efficacy endpoint. But the regulator argued that the data did not support the effectiveness of the treatment.
Sydnexis has requested that the adcomm include “practicing pediatric ophthalmologists and optometrists, as they understand the long-term challenges facing patients and families every day,” CEO Perry Sternberg said in a release.
The company explained that compounded versions of low-dose atropine are currently used by many U.S. physicians to manage PPM, but that these products do not undergo FDA scrutiny for safety, effectiveness, manufacturing consistency and labeling.
SYD-101 has been approved in Europe and the U.K.
The FDA has accepted BioMarin’s submission for full approval of Voxzogo as a treatment for children with achondroplasia, a type of dwarfism.
The U.S. regulator granted an accelerated nod in the indication for Voxzogo in 2021 and expanded the label to include children age 5 and younger in 2023. The target decision date for the full nod is set for February 28 of next year.
The submission is backed by three studies, which have shown the ability of Voxzogo, which is injected once daily, to allow meaningful improvements in growth and skeletal health outcomes in children with the disorder.
Voxzogo delivered sales of $927 million in 2025, which were up 26% over the prior year. BioMarin has new competition in the achondroplasia market from Ascendis Pharma and its once-weekly injection Yuviwel, which was approved in February.
UPDATED: Friday, July 10 at 10:20 a.m. ET
The United Kingdom’s drug value watchdog NICE has urged against NHS coverage of Amgen’s oral cancer med Lumakras (sotorasib)—sold as Lumykras in Europe—in new draft guidance, potentially limiting future uptake of the med by adults with KRAS G12C mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
In the guidance published (PDF) late this week, NICE said that Amgen’s drug shouldn’t be used in this lung cancer population when the cancer has progressed on platinum-based chemotherapy or a PD-(L)1 immunotherapy, or when those treatments aren’t well tolerated.
Until now, Lumykras has been covered in the U.K. under a managed access program, and NICE clarified that its recommendation shouldn’t affect treatment funded before its guidance was published. If the guidance is ultimately applied, NHS England and Amgen have an “arrangement” to ensure that people who have previously started treatment will continue to have access to Lumykras until it’s deemed appropriate to stop treatment.
In rationalizing the guidance, NICE noted that although clinical evidence shows that Lumykras increases the time people have before their condition worsens compared to the chemotherapy docetaxel, it is “uncertain how much longer people live with sotarasib compared with docetaxel,” citing differences and limitations in clinical and real-world evidence sources.
“Because of the limitations in the clinical evidence there is uncertainty in the economic model, including how to model the long-term benefits of sotorasib,” NICE explained.
In an emailed statement, an Amgen spokesperson said the company does "not believe NICE’s decision fully reflects the breadth of real-world evidence, including NHS experience over the last four years, clinical expert perspective and the impact on lung cancer patients who have limited treatment options.
"We will continue to engage constructively with NICE, the NHS, clinicians and patient organizations to explore all available options to support continued access for eligible patients," the spokesperson added.
Also in the U.K., the country’s drug authority, the Medicines and Healthcare products Regulatory Agency (MHRA), has cleared Boehringer Ingelheim’s nerandomilast, also known as Jascayd, as a new treatment for adults with the lung disease idiopathic pulmonary fibrosis (IPF), as well as progressive pulmonary fibrosis (PPF).
In both conditions, lung tissue becomes scarred over time, causing increasing breathing difficulties for patients.
The U.K. nod marks the first in Europe for Jascayd, which snagged the first new IPF approval in more than a decade when the FDA greenlit it in the condition last October. The remaining IPF market is dominated by Roche’s Esbriet and Boehringer’s own Jascayd predecessor Ofev.
IPF could affect up to 3.6 million people around the world, Boehringer Ingelheim said last year. Still, underdiagnosis and misdiagnosis mean the number of patients currently receiving treatment is much lower, per the company.
Stateside, the FDA has signed off on Accord BioPharma’s second biosimilar referencing pegfilgrastim, also known as Amgen’s chemotherapy immune system booster Neulasta.
Accord, which is the U.S. specialty unit of Intas Pharmaceuticals, announced the approval of its biosim Ennumo Thursday to decrease the incidence of infection, in the form of febrile neutropenia, in adults and kids from the age of newborn and up with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs linked to a significant incidence of febrile neutropenia.
The green light also covers the biosimilar’s ability to increase survival in patients acutely exposed to myelosuppressive doses of radiation, matching the indications of Neulasta.
The nod makes Accord the only U.S. company with two Neulasta biosimilars on deck, with Ennumo now joining its previously approved Udenyca. It also propels Accord on its goal to launch 20 biosimilars in the U.S. by 2030, the company said late this week.
UPDATED: Tuesday, July 7 at 10:15 a.m. ET
AbbVie and Genmab's CD20xCD3 bispecific Tepkinly, known as Epkinly in the U.S., has won European Commission approval for use in combination with lenalidomide and rituximab in previously treated follicular lymphoma (FL).
The EU approval follows an FDA nod for the same indication in November 2025. The green light is based on results from the phase 3 Epcore FL-1 trial, which showed that the combination reduced the risk of progression or death by 79% versus lenalidomide-rituximab alone.
FL is typically a slow-growing form of non-Hodgkin lymphoma (NHL). As the second most common form of NHL, FL accounts for 20% to 30% of all NHL cases, with higher incidence rate in European populations (11%-29%) versus non-European populations (2%-18%), according to AbbVie.
UPDATED: Monday, July 06 at 10:45 a.m. ET
With several years passed since the end of the COVID-19 pandemic, Robert F. Kennedy Jr.’s Department of Health and Human Services has nixed the emergency use authorizations (EUAs) that remain for several drugs, biological products and medical devices, determining that “the circumstances that justified these emergency authorities no longer exist.”
“By ending these COVID-19 emergency use authorization declarations, we're reinforcing public confidence that emergency authorities are temporary and targeted,” Kennedy said in a statement posted to the HHS’ website last week.
Many well-known COVID-19 vaccines and treatments, from Pfizer and BioNTech’s vaccine Comirnaty to the antivirals Paxlovid and Gilead’s Veklury, possess traditional, full approvals from the FDA, while other products like Merck & Co.’s Lagevrio (molnupiravir) still hold EUAs dating from the pandemic.
In justifying its decision in a Federal Register notice, the HHS argued that reliance on authorized drugs and biological products has waned, with other vaccines, convalescent plasma products and therapeutics for all age groups and spectrum of disease now approved through traditional pathways.
The termination of the EUAs for drugs and biological products will take effect in a year.
At least one drugmaker, Invivyd—whose authorized prophylactic antibody Pemgarda (pemivibart) has been caught in the crossfire—suggested that it is in dialogue with the FDA about next steps for its product. That said, “to date, neither HHS nor FDA has expressly provided Invivyd with such written advice regarding a Pemgarda regulatory approval pathway,” the company explained in a release Monday.
Nevertheless, the “end of a formal emergency for COVID products is in many ways overdue,” Marc Elia, Invivyd’s board chairman, said in a statement.
He continued: “At Invivyd, we believe Pemgarda has sufficient clinical and post-authorization data to support Biologics License Application (BLA) submission and approval, and we regret that procedural uncertainty has needlessly intruded into our work on behalf of vulnerable Americans, who may find these headlines worrying and confusing.”
UPDATED: Wednesday, July 1 at 2:00 p.m. ET
The FDA has assigned a target decision date of Feb. 28, 2027, for Sarepta Therapeutics’ applications that seek to convert the accelerated approvals of Amondys 45 and Vyondys 53 to full approvals.
Sarepta filed the two exon-skipping drugs for the treatment of Duchenne muscular dystrophy (DMD) despite missing the primary endpoint of a confirmatory trial called Essence. The company has pointed to an average 0.05 steps/second difference in favor of the therapies on a 4-step ascend velocity test designed to measure DMD patient mobility, as well as real-world evidence, to support its case. It has also suggested that the COVID-19 pandemic confounded the Essence readout.
“In populations this small and in a disease where damage unfolds over years, real-world experience is essential to understanding how these therapies impact the disease course,” Louise Rodino‑Klapac, Ph.D., Sarepta’s president of research & development and technical operations, said in a June 30 statement. “We look forward to working with the FDA throughout the review.”
In a Tuesday note, Jefferies analysts estimated that investors are assuming a 50%-plus probability of approval. The analysts suggested that the FDA may allow the two drugs to remain in the market even if the agency declined to convert the accelerated approvals.