FDA Related News

Human Drugs

New Medication Guides for Forms of 10 Drugs

FDA releases a list of 10 drugs for which new medication guides are available.

Medical Devices

3D Printed Swab Town Hall

A CDRH virtual town hall focused on a collaboration between FDA, the VA, and the NIH to develop 3D printing of nasal swabs to ease a supply shortage.

Human Drugs

Hikma Pharma Gains OK for Generic Vascepa

Hikma Pharmaceuticals gains approval from FDA for its icosapent ethyl capsules, 1 gm, the generic equivalent of Amarin Pharmaceuticals Vascepa.

Human Drugs

FDA Approves Kynmobi for Parkinsons Off Time

FDA approves Sunovions Kynmobi for Parkinsons disease off-time use.

Human Drugs

Takeda Gets Expanded OK for Alunbrig

FDA approves a Takeda Pharmaceutical Company NDA for Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-...

Medical Devices

FDA Posts List of Removed Antibody Tests

FDA releases a list of antibody tests that the agency expects will not be marketed or distributed for several reasons.

Human Drugs

FDA Sentinel Collaboration on Covid Drugs

The FDA Sentinel Operations Center at the Harvard Pilgrim Health Care Institute is working with TriNetX on projects to assess usage of medications use...

Human Drugs

Biota Biosciences Recall 3 Drug Products

Biota Biosciences recalls five lots of Cannabidiol Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables because they were marketed withou...

Stericycle Predicts Surge in FDA Enforcement After Pandemic

Stericycle says medical device and drug manufacturers should expect a significant uptake in FDA regulatory and enforcement action once the nation move...

Human Drugs

Chiesi Rare Diseases NDA Approved

FDA approves a Chiesi Global Rare Diseases NDA for Ferriprox (deferiprone) twice-a-day tablets for treating patients with transfusional iron overload ...