FDA Related News

Human Drugs

CGMP Issues at Indias Wizcure Pharmaa

FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.

Human Drugs

Chinese Drug Firm Refuses FDA Record Request

FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter drug manufacturing op...

CBER SOPP on Implementing, Managing REMS

CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.

Human Drugs

FDA Novel Drug Approvals Remain Steady in 2026 First Half

FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent year...

Human Drugs

Complete Response on Liver Imaging Agent

FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.

Medical Devices

BMC Medical Selling Adulterated, Misbranded CPAPs: FDA

FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in place for the devices....

Human Drugs

FDA OKs Casgevy for Younger Children

FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.

Medical Devices

Quality System, Other Violations at 3B Medical

FDA warns 3B Medical about multiple violations in its work manufacturing a software device used with ventilator systems imported from China.

Medical Devices

AseptiKits Marketing Adulterated, Misbranded Devices: FDA

FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.

Human Drugs

FDA Approves BESREMi Pen for Polycythemia Vera

FDA approves PharmaEssentias BESREMi injection pen to treat polycythemia vera.