Biocon has resolved FDA concerns about a plant in India, setting it and Mylan up to potentially win FDA approval for the first Herceptin biosimilar.
Call it a big day for Roche at the FDA, as the drug giant picked up two critical approvals on Thursday.
Rare disease biotech Ultragenyx has its first FDA nod in Mepsevii, an enzyme therapy expected to carry a high price to treat a tiny group of patients.
AstraZeneca is about to find out whether its third-to-market respiratory biologic can stand out from a crowd that includes rivals GSK and Teva.
Back in August, Novartis published findings from the phase 3 Cantos trial of Ilaris that weren't "fully compelling to payers."
The new digital Abilify is a breakthrough for Proteus Digital Health and its patient-tracking products, but not so much for Abilify's maker, Otsuka.
With time running short, EU members have been asked to set aside parochial interests in their pick for a new city to host the EMA.
President Donald Trump tweeted his nomination for ex-Eli Lilly executive Alex Azar as HHS secretary Monday morning.
FDA Commissioner Scott Gottlieb has unveiled yet another move to step up competition in the generics business.
Merck’s drug for chemo-induced nausea and vomiting has some new competition.