Former FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein say the Trump administration and FDA cant afford to repea...
Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progressiva.
FDA says it will temporarily allow the distribution of some rifampin and rifapentine with nitrosamine impurities to avoid shortages while manufacturer...
FDA commissioner Stephen Hahns controversial remarks exaggerating the efficacy of convalescent plasma touches off a wider examination of those advisin...
Federal Register notice: FDA announces a 9/10 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic...
Smiths Medical recalls specific software versions used with its Medfusion 3500 and 4000 Syringe Pumps because of an error that may lead to fluid/medic...
Leaders of the House Energy and Commerce Committee ask FDA commissioner Stephen Hahn what steps he is taking to ensure that science prevails over poli...
FDA warns Puerto Ricos Banco Vida Corp. about violations involving its umbilical cord blood products.