FDA lifts a partial clinical hold on a Marker Therapeutics Phase 2 trial of an investigational drug to treat post-transplant acute myeloid leukemia.
FDA warns Reddy Naturals that it is marketing unapproved and misbranded new drugs.
FDA issues a guidance with an overview of the new Safer Technologies Program for some medical devices and device-led combination products.
Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Alec Burlakoff.
Federal Register notice: FDA issues an order to permanently debarring former Cumberland Distribution owner Jerrod Nichols Smith from providing service...
Federal Register notice: FDA makes available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Adm...
Nostrum Laboratories recalls one lot of metformin HCl extended release tablets after it was determined to contain levels of nitrosamine impurities abo...
FDA releases an FDA-483 with four observations from an inspection at the Stokes Healthcare outsourcing facility.