FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

FTC Wants AbbVie AndroGel Appeal Denied

The Federal Trade Commission asks the Supreme Court not to hear AbbVies appeal of lower court decisions holding that it engaged in sham litigation to ...

Human Drugs

Probation for Unapproved Drug Distribution Conspiracy

The Justice Department says a Georgia man has been sentenced to five years probation for conspiracy to distribute unapproved drugs and unlawful smuggl...

Human Drugs

EUA for Vir/GSK Covid Antibody Treatment

FDA grants an EUA for Sotrovimab, a monoclonal antibody treatment for Covid-19 developed by Vir Biotechnology and GlaxoSmithKline.

Human Drugs

Justice Department Hits Eli Lilly with Subpoena

U.S. Department of Justice issues a subpoena to Eli Lilly requesting documents about its troubled manufacturing site in Branchburg, NJ.

Human Drugs

FDA Approves Progenics Pylarify for Prostate Cancer Imaging

FDA approves Progenics Pharmaceuticals Pylarify for PET imaging of prostate-specific membrane antigen positive lesions in some men with prostate cance...

Human Drugs

Metro Drugs Sterile Drug Deficiencies Noted

FDA cautions New York Citys Metro Drug about adulterated and misbranded sterile drug products.

Medical Devices

Transition from Non-Approved Disposable Respirators: FDA

FDA says healthcare personnel and facilities can transition away from using non-NIOSH-approved disposable respirators due to an increased supply of ne...

Medical Devices

Acutus Medical Atrial Fibrillation Trial Gets Go Ahead

FDA gives Acutus Medical the green light to initiate its atrial fibrillation clinical trial to assess the AcQBlate Force Sensing Ablation Catheter and...

Human Drugs

FDA Priority Review for Janssen Myeloma BLA

FDA accepts for priority review a Janssen BLA for an investigational treatment for relapsed/refractory multiple myeloma.

Medical Devices

FDA Issues 2 Draft Device Surveillance Guidances

FDA publishes two draft guidances on the continued surveillance of certain FDA-approved and cleared medical devices.