FDA issues an emergency use authorization for Mercks molnupiravir to treat mild-to-moderate Covid-19 in some adults.
Padagis recalls three lots of 12 g spray bottles of nitroglycerin lingual spray labeled for Perrigo due to the potential for a defective dispenser.
FDA grants an emergency use authorization for Pfizers Paxlovid, the first oral treatment for some Covid-19 cases.
FDA tentatively approves Amphastars vasopressin injection, a generic form of Pars Vasostrict.
FDA sets a 6/22 PDUFA action date for an Amylyx NDA for its Alzheimers investigational drug.
FDA clears Bioventus neXus bone scalpel handpiece.
FDA issues a guidance with recommendations on non-clinical and clinical studies for medical devices to treat benign prostatic hyperplasia.
FDA approves fast track designation for an acute myeloid leukemia indication for Celularitys CYNK-001 cell therapy.