Sarepta Therapeutics halts shipments of its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchen...
FDA warns Indias Kenil Private Healthcare about CGMP violations in its production of finished drugs.
FDA approves updated labeling on Pfizers s Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for men with metastatic castration-resista...
FDA launches the Commissioners National Priority Vouchers to speed drug reviews for companies with products that are aligned with national priorities ...
Aldeyra Therapeutics resubmits an NDA for reproxalap to treat the signs and symptoms of dry eye disease.
FDA warns Chinas Zhejiang Huahai Pharmaceutical Co. about CGMP violations in its production of finished drugs.
The latest semiannual report issued by the HHS Office of Inspector General raises questions about specific FDA accelerated drug approvals.
A ProPublica investigative report details how a secret small group of FDA officials has approved exemptions for products from overseas factories that ...
