FDA accepts for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofibromatosis type 1 an...
CGMP consultant Dave Elder analyzes a draft International Conference on Harmonization guidance on technical and regulatory considerations for drug pro...
Former CDRH branch chief Morris Waxler tells CBS News LASIK eye surgery should be pulled from the market due to complications.
FDAs Endocrinologic and Metabolic Drugs Advisory Committee votes to not recommend approval of Eli Lilly and Boehringer Ingelheims empagliflozin 2.5 mg...
FDA says the Botanical Safety Consortium has been formally convened under a memorandum of understanding between FDA and two research groups
FDA approves BeiGenes Brukinsa capsules to treat some adults with mantle cell lymphoma.
FDA releases an FDA-483 with four inspection observations on an inspection at Isorx Corp.
FDA clears a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden in can...