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.
Federal Register notice: FDA sends to OMB an information collection revision entitled Premarket Notification of Devices.
FDA posts a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests...
FDA approves an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) Linzess (linaclotide) to treat functional constipation in pediatri...
Federal Register notice: FDA seeks comments on an information collection extension on voluntarily submitted medical device regulatory misconduct alleg...
