FDA Related News

Human Drugs

Oklahoma Court Overturns J&J Opioid Case Ruling

The Oklahoma Supreme Court says a lower court erred in determining that J&J violated the states public nuisance law in the way it marketed prescriptio...

Human Drugs

Rivoceranib Gets Orphan Status for Liver Cancer

FDA grants Elevar Therapeutics an orphan drug designation for rivoceranib and its use for treating hepatocellular carcinoma.

Human Drugs

FDA Accepts Jardiance sNDA for CV Risk Reduction

FDA accepts for priority review a Boehringer Ingelheim and Eli Lilly supplemental NDA for Jardiance (empagliflozin) 10 mg for reducing the risk of car...

Human Drugs

Naviswiss Hip Replacement Navigator Cleared

FDA clears a Naviswiss 510(k) for its Naviplan, a digital pre-operative planning application to assist orthopedic surgeons in performing navigated tot...

FDA OKs Resumption of Inovio Covid Vaccine Trial

FDA authorizes Inovio to proceed with the Phase 3 INNOVATE segment of its investigative DNA Covid vaccine clinical trial.

Human Drugs

FDA Clinical Hold on Pfizer Hemophilia A Trial

FDA places a clinical hold on a Pfizer Phase 3 trial of a gene therapy candidate to treat hemophilia A.

Medical Devices

Ellume Covid Test Recall is Class 1: FDA

FDA says the Ellume recall of certain lots of its Covid-19 home test due to an unacceptable level of false-positive results is Class 1.

Medical Devices

HeartVista MRI Software Cleared for Siemens Scanner

FDA clears a HeartVista 510(k) to provide its artificial intelligence-assisted One Click MRI acquisition software on Siemens Healthineers MRI scanners...

Medical Devices

Aligned Medical Solutions Recalls Convenience Kits

Aligned Medical Solutions recalls its custom convenience kits due to the potential for the plunger on the Cardinal Health Monoject Flush Prefilled Syr...

Medical Devices

Meridian Bio EUA for Covid Assay

FDA grants Meridian Bioscience an emergency use authorization for its Revogene SARS-CoV-2 assay, a molecular diagnostic test for the qualitative detec...