FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder...
FDA classifies as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says i...
FDA approves an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections.
FDA updates a Class 1 recall (correction) of Megadyne Medical Products Mega Soft patient return electrode models to reiterate the devices should not b...
FDA posts a draft guidance on Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institution...
Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conjugates.
Federal Register: FDA announces a publication containing modifications the agency is making to the list of standards it recognizes for use in premarke...
FDA grants full approval to Johnson & Johnsons Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of certain p...
