FDA reviewers dismiss new analyses and data from Amylyx that were intended to provide confirmatory evidence to support approval of its amyotrophic lat...
Federal Register notice: FDA announces the issuance of a priority review voucher to BioMarin Pharmaceutical for a rare pediatric disease product appli...
FDA approves a Boehringer Ingelheim NDA for Spevigo (spesolimab) as a treatment option for generalized pustular psoriasis flares in adults.
Federal Register notice: FDA advisory committee reviews GlaxoSmithKline NDA for daprodustat, indicated for treating anemia due to chronic kidney disea...
FDA approves an Azurity Pharmaceuticals NDA for Konvomep (omeprazole and sodium bicarbonate for oral suspension), a proton pump inhibitor for treating...
FDA grants Vibrant Gastro de novo marketing authorization for its Vibrant, an orally administered drug-free capsule that provides mechanical stimulati...
FDA approves an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for combination use with gemcitabine and cisplatin for adult patients with local...
Federal Register notice: FDA announces an 11/8 Pulmonary-Allergy Drugs Advisory Committee meeting to review AstraZeneca NDA for a combination metered ...
