The FDA has withdrawn its approval of Makena, Covis Pharmaceutical’s drug to reduce the risk of pre-term birth in at-risk women, citing the lack of a favorable postmarket benefit-risk assessment…

Arbutus Biopharma and Genevant Sciences have filed a complaint in a federal court alleging that Pfizer and BioNTech violated five patents related to their messenger RNA (mRNA) delivery technology used…

The European Medicines Agency (EMA) is updating its Priority Medicines (PRIME) program to include new ways to track a product’s progress toward approval and to get more timely advice from…

Double-checking that a Form 483 is factually correct — and that the observations make sense — are two of the most important things a firm can do when given the…

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), explained her center’s top budget priorities for fiscal 2024 — highlighting steps to shore up the drug…

In a move to help prevent or mitigate shortages, the FDA is asking drugmakers to provide more information regarding manufacturing disruptions that could affect finished drugs and biological products as…

AdvaMed has submitted an amicus brief to the U.S. Supreme Court in support of two supermarket chains accused of violating the False Claims Act by misreporting their drug prices, arguing…

Source: Drug Industry Daily

The FDA has told Fullerton, Calif.-based Synovo Production to cease manufacture of its hip cup replacement system because the company failed to notify the agency about significant changes to the…

The FDA handed Advanced Accelerator Applications a five-observation Form 483 after conducting an inspection of its Millburn, N.J., facility for failure to establish written procedures for production and process controls…