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. Source: Drug…

Sovereign Pharmaceuticals’ Texas facility received a Form 483 after an inspection in November found numerous problems in the facility, including the building’s construction. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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…

China’s Ministry of Human Resources and Social Security has expanded the list of drugs covered by state insurance, adding more than 300 drugs to the catalog since it was last…

The Supreme Court ruled to limit the reach of patent protections on single components of a multicomponent product exported for manufacture abroad, reversing an appellate court decision in a unanimous…

The Maryland General Assembly is considering two bills that would require pharmaceutical companies to notify the state ahead of drug price increases. Source: Drug Industry Daily