FDA granted accelerated approval to Ocaliva, the first new medicine for primary biliary cholangitis in nearly 20 years.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
A once-per-month injection for MS developed by Biogen and AbbVie received FDA approval.
The world’s first life-saving gene therapy for children, developed by GlaxoSmithKline and Italian scientists, was approved for sale in Europe.
Titan Pharmaceuticals announced that the U.S. FDA approved Probuphine (buprenorphine) implant for long-term maintenance of opioid dependence.
FDA gave Tecentriq accelerated approval to treat specific types of advanced bladder cancer.
The VENTANA PD-L1 (SP142) Assay was approved as a complementary diagnostic for Tecentriq immunotherapy.
Vifor Fresenius Medical Care Renal Pharma obtains rights to commercialize RAYALDEE in Europe, Canada and certain other international markets; OPKO Health to receive up to $282 million in upfront and milestone payments, plus tiered double-digit royalties.
Acadia Pharmaceuticals Inc’s drug for psychosis linked to Parkinson’s disease was approved in the United States on Friday, becoming the first treatment for the condition to get a nod in the country. The U.S. Food and Drug Administration, however, asked Acadia to include a black-box warning, its strictest warning, on the drug’s label for an […]
Bayer announced U.S. FDA approval of Gadavist (gadobutrol) injection for use with magnetic resonance angiography to evaluate known or suspected supra-aortic or renal artery disease.
The U.S Food and Drug Administration approved Abiomed Inc’s heart pump to treat patients who suffer cardiac shock after heart attack or heart surgery, sending its shares up about 4 percent in extended trading. Cardiac shock is a life-threatening emergency condition where the heart is suddenly unable to pump enough blood and oxygen to support […]