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FDA accepts for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As...[ Price : $8.95]
Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in...[ Price : $8.95]
Johnson & Johnson subsidiary Medical Device Business Services agrees to pay $10 million to settle allegations under the False Clai...[ Price : $8.95]
Federal Register notice: FDA updates its ongoing listing of issued and reissued Emergency Use Authorizations for medical devices r...[ Price : $8.95]
FDA issues a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contraceptives.[ Price : $8.95]
Pfizer and BioNTech file an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 based on Phase 3 dat...[ Price : $8.95]
Fresenius Kabi recalls a single lot of dexmedetomidine HCl 0.9% sodium chloride injection, 200 mcg/50 mL (4 mcg /mL) in a 50 mL vi...