A brief filed by the U.S. Solicitor General on behalf of FDA calls on the Supreme Court to hear the agencys appeal of a 5th Circuit Court of Appeals d...
FDA approves an Evive Biotech BLA for Ryzneuta (efbemalenograstim alfa), indicated to decrease the incidence of infection, as manifested by febrile ne...
Entrada Therapeutics says an ongoing clinical hold against the companys Phase 1 trial of ENTR-601-44 in Duchenne muscular dystrophy patients remains i...
Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effective...
FDA publishes an immediately-in-effect guidance on developing drugs and biologics to prevent or treat some Covid-19.
Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.
FDA declines to ban music in all DTC ads during the presentation of risk information.
FDA clears a Masimo 510(k) for Masimo W1 medical watch for providing continuous real-time oxygen saturation and pulse rate for over-the-counter and pr...
