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Bipartisan lawmakers introduce legislation in the Senate and House to close a patent-listing loophole that drug manufacturers use ...[ Price : $8.95]
An FDA advisory committee votes 9 to 3 that the benefits of Alnylam Pharmaceuticals patisiran (Onpattro) outweigh its risks for tr...[ Price : $8.95]
FDA medical reviewers question the efficacy of Alnylam Pharmaceuticals patisiran for an expanded population sought in an sNDA.[ Price : $8.95]
FDA publishes its FY 2022 report on GDUFA science and research outcomes.[ Price : $8.95]
FDA warns Safecor Health that its Columbus, OH-based drug manufacturing facility has significant violations of CGMP requirements f...[ Price : $8.95]
FDA warns Switzerlands Similasan AG that it is marketing unapproved new ophthalmic drugs that are manufactured with significant CG...[ Price : $8.95]
FDA warns eight companies that they are illegally marketing unapproved ophthalmic drugs.[ Price : $8.95]
CDER says the legal standard for withdrawing Oncopeptides ABs Pepaxto has been met and the agency should withdraw the drug to prot...