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BioMarin is calling it quits for its Duchenne muscular dystrophy candidate and three related products in its pipeline after the EMA’s Committee for Medicinal Products for Human Use signaled that it would not back the candidate. Read More
In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More
Allergan has clinched FDA approval for its hypertension treatment Byvalson, the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker in the U.S. Read More
A second FDA complete response letter to Adamis Pharmaceuticals for its acute anaphylaxis candidate requests an extension of its human factors and reliability studies. Read More