FDA Related News

Human Drugs

FDA Priority Review for Hunter Syndrome Therapy

FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.

FDA Inspectors Say Conditions Still Hard

A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support staff.

Human Drugs

Priority Review for Mercks Winrevair

FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.

Biologics

Vaccine Regulation Now a Political Process: Gottlieb

Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...

Human Drugs

Sandoz Recalls 1 Cefazolin Lot

FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were included in a Cefazolin...

Medical Devices

FDA Clears Philips SmartSpeed Precise Software

FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.

Human Drugs

Myelodysplastic Syndrome Drug Development Guide

FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.

Biologics

Positive Phase 3 Results for Moderna Flu Vaccine

Moderna says its mRNA-1010 investigational seasonal flu vaccine achieved very positive results in a Phase 3 efficacy trial.

Human Drugs

Bioresearch Monitoring Violations by Dr. Peter Michael

FDA warns Hialeah, FL-based physician Peter Michael about failing to follow the investigation plan in two clinical studies.

Human Drugs

Regenerons Lynozyfic Approved for Some Myelomas

FDA gives accelerated approval to Regenerons Lynozyfic for some multiple myelomas.