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.
FDA warns Switzerlands Similasan AG that it is marketing unapproved new ophthalmic drugs that are manufactured with significant CGMP violations.
FDA warns eight companies that they are illegally marketing unapproved ophthalmic drugs.
CDER says the legal standard for withdrawing Oncopeptides ABs Pepaxto has been met and the agency should withdraw the drug to protect public health du...
