FDA grants Futura Medical a de novo marketing authorization for over-the-counter MED3000, a topical gel formulation for treating erectile dysfunction.
Federal Register notice: FDA issues an order to debar Luis Anarbol Moran for five years from importing any drug into the U.S.
Federal Register notice: FDA seeks comments on an information collection extension entitled Orphan Drugs 21 CFR Part 316.
BIO suggests revisions to an FDA strategic plan for modernizing the agencys data and technology systems.
Viatris asks FDA to require additional PK and PD studies to support an ARS Pharmaceuticals NDA for its ARS-1 epinephrine nasal spray.
FDA approves Ipsens Bylvay (odevixibat) for an expanded use treating cholestatic pruritus in patients aged 12 months and older with Alagille syndrome...
FDA reviewers recommend that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the XBB-lineage variant...
Federal Register notice: FDA sends to OMB an information collection extension entitled Adverse Event Program for Medical Devices.
