Topic:

Regulatory

Latest Headlines

Latest Headlines

Ranbaxy fights FDA for killing its approval to make generic Nexium

This month, the FDA yanked the approvals it granted Ranbaxy to make generics of two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy has now filed a federal lawsuit against the FDA for canceling the approvals.

FDA to more than double staff in China as visa issues appear resolved

The FDA is extending its tentacles deeper into China, which exported medical devices worth $3.5 billion to the U.S. in 2012, according to the U.S. Department of Commerce.

FDA orders CytRx to halt patient enrollment after death of a cancer patient

CytRx has run into an unexpected roadblock with its cancer drug conjugate aldoxorubicin, slamming the brakes on new patient recruitment in all their clinical trials after the FDA dropped a partial clinical hold on the program. According to the biotech the hold was forced by the death of a patient who was given the drug through a compassionate use program.

Getting more FDA inspectors in China on Hamburg's agenda for trip to China

For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.

FDA Commissioner to talk drug safety with top Chinese officials

While in China for the International Summit of Heads of Medicines Regulatory Agencies, FDA Commissioner Margaret Hamburg will meet with top Chinese regulatory officials about working cooperatively on drug and food safety.

UPDATED: FDA panel recommends approval of Alcon intraocular lens

FDA's Ophthalmic Devices Advisory Committee panel overwhelming recommended PMA approval of Alcon's ReSTOR Multifocal Toric Intraocular Lens for patients undergoing cataract eye surgery who are astigmatic and suffer from presbyopia.

FDA reverses an embarrassing rejection of Sanofi's Lemtrada, OKs MS drug

Late on Friday the FDA put out the word that it has reversed its earlier decision against Sanofi's multiple sclerosis drug Lemtrada, agreeing to allow the pharma giant the right to market the treatment--with some tight controls on just who will get this drug for the relapsing form of the disease.

FDA continues crackdown on equine drugmakers

The FDA has sent letters to 9 companies--all of which market drugs to treat ulcers in horses--warning that they are improperly selling the products without first obtaining FDA approval.

Roche's Avastin wins FDA green light in ovarian cancer

Roche's Avastin is now two-for-two on converting recent FDA priority review designations into label expansions. Just three months after the cancer giant nabbed the agency's blessing for use in cervical cancer, regulators have approved the drug in combination with chemotherapy as a treatment for platinum-resistant, recurrent ovarian cancer.

Actavis could make out big time with FDA's knock to Mallinckrodt, Kudco drugs

While the industry is fixated on whether Actavis will save Allergan from a hostile takeover by Valeant or whether Pfizer might be sizing up a run at Actavis, there was a development Thursday that holds huge upside potential for Actavis. That was the FDA's decision to reclassify Mallinckrodt's Concerta generic as not making the grade in equivalence.