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 sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease.
Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles.
Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications From Firms to Health C...
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Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effective...
