2,736 Results
FDA cited NeilMed Pharmaceuticals for glycerin identity testing failures and unqualified supplier use, flagging DEG/EG contamination risk in OTC drug manufacturing.
FDA closes NeilMed Pharmaceuticals' 2023 Warning Letter but flags ongoing inspection oversight and sustained compliance expectations.
FDA's CBER releases draft guidance on single-BLA submissions for individualized genome editing products, with comments due 27 November 2026.
FDA's CBER issued a warning letter to Malaysia-based Beaute Bounty for selling unlicensed stem cell and placenta biologics to U.S. consumers online.
FDA cited Best Chinese Medicines LLC for marketing five unapproved drug products, flagging disease treatment claims across product pages and blog content.
Alembic Pharmaceuticals receives USFDA final approval for Valganciclovir oral solution, indicated for CMV retinitis in AIDS patients.
AbbVie files BLA for etentamig, a BCMA x CD3 bispecific antibody, backed by Phase 3 CERVINO data showing 74% ORR in relapsed/refractory multiple myeloma.