FDA warns Irving, TX-based Reset Technology Corp. about Quality System and other violations in its production of two dental devices.
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.
