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FDA approves Fresenius Kabis Stimufend biosimilar for Amgens Neulasta.[ Price : $8.95]
FDA reviewers dismiss new analyses and data from Amylyx that were intended to provide confirmatory evidence to support approval of...[ Price : $8.95]
Federal Register notice: FDA announces an 11/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review AstraZeneca NDA for a ...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of a priority review voucher to BioMarin Pharmaceutical for a rare pediatric d...[ Price : $8.95]
FDA approves a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis flares i...[ Price : $8.95]
Federal Register notice: FDA advisory committee reviews GlaxoSmithKline NDA for daprodustat, indicated for treating anemia due to ...[ Price : $8.95]
FDA approves an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump in...[ Price : $8.95]
FDA grants Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule that provides ...