FDA Related News

Medical Devices

Update on Drager Neonatal Incubators

An FDA safety update says it has determined that new neonatal incubators by Drager (also known as Draeger) do not need to be run for a week before cli...

Human Drugs

Agios Mitapivat Study Meets Endpoint

Agios Pharmaceuticals reports that the Phase 3 ENERGIZE study of Pyrukynd (mitapivat) in adults with non-transfusion-dependent alpha- or beta-thalasse...

Human Drugs

FDA 2023 Novel Drug Approvals Up

FDA says CDER approved 55 new drugs in 2023, almost 50% more than in 2022.

FDA Guidance Best Practices Plan

FDA asks for comments on a report on agency best practices for guidance documents.

FDA General

Commerce Committee Probes FDA Internal Disputes

The U.S. House Energy and Commerce Committees Republican leadership opens an investigation into FDAs handling of internal scientific disagreements rel...

Human Drugs

Laurus Synthesis FDA-483

FDA releases the form FDA-483 issued to Indias Laurus Synthesis with five inspection observations.

Human Drugs

Torrent Pharmaceuticals FDA-483

FDA releases the form FDA-483 issued following an inspection at Indias Torrent Pharmaceuticals drug manufacturing facility.

Human Drugs

No FDA Funding for RADAR: Public Citizen

Public Citizen asks FDA to revise its planned research on the misuse of drugs and other substances to ensure that no funding goes to the Researched Ab...

Medical Devices

FDA Alert on Synovo Hip Implants

FDA alerts healthcare providers to not purchase or implant Synovos Total Hip System because modifications to the original device design were not clear...

Biologics

EUA Filed for Covid Prevention in Immunocompromised

Invivyd seeks FDA emergency use authorization for VYD222, which is described as a broadly neutralizing, half-life extended monoclonal antibody candida...