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The EMA’s Committee for Medicinal Products for Human Use recommended approvals for six drugs within the EU to treat a range of conditions from an endocrine disease to nausea. Read More
Sovereign Pharmaceuticals’ Texas facility received a Form 483 after an inspection in November found numerous problems in the facility, including the building’s construction. Read More
The FDA will have to create a task force to identify regulations to repeal or modify under an executive order signed by President Trump last week. Read More
The U.S. solicitor general and several generics makers have filed U.S. Supreme Court briefs in support of reversing a Federal Circuit ruling that orders sponsors to wait six months after an FDA approval to launch a biosimilar. Read More