FDA accepts for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoholic steatohepatitis...
Federal Register notice: FDA determines that Gemini Laboratories Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were withdrawn from sale for reason...
Pharmaceutical Research and Manufacturers of America says FDA should take a more flexible approach to determining good cause for failing to meet postm...
Bipartisan lawmakers introduce legislation in the Senate and House to close a patent-listing loophole that drug manufacturers use to extend their excl...
An FDA advisory committee votes 9 to 3 that the benefits of Alnylam Pharmaceuticals patisiran (Onpattro) outweigh its risks for treating cardiomyopath...
FDA medical reviewers question the efficacy of Alnylam Pharmaceuticals patisiran for an expanded population sought in an sNDA.
FDA publishes its FY 2022 report on GDUFA science and research outcomes.
FDA warns Safecor Health that its Columbus, OH-based drug manufacturing facility has significant violations of CGMP requirements for finished drugs.
