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Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications From Firms to Health C...
In a likely attempt to rebut a critical BMJ investigation, FDA and CDC officials explain, defend, and praise the Vaccine Adverse Event Reporting Syste...
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Federal Register notice: FDA determines that Indiviors Buprenex (buprenorphine HCl) injection, 0.3 mg/mL, was not withdrawn due to safety or effective...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.
