Unomedical recalls certain VariSoft Infusion Sets due to the risk that the devices connector may detach from the set.
FDA accepts for priority review an Abeona Therapeutics BLA for pz-cel (prademagene zamikeracel) for treating patients with recessive dystrophic epider...
Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Treatment or Prevention....
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Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effective...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Federal Register notice: FDA makes available a draft guidance entitled Translation of GLP Study Reports: Questions and Answers.
