FDA Related News

FDA General

RFK Jr. Aims to Free FDA from Corporate Capture

HHS secretary-nominee Robert F. Kennedy Jr. vows to free the agencies, including FDA, from the smothering cloud of corporate capture.

Biologics

Dupixent Supplemental BLA Filed for Urticaria

FDA accepts for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) for treating chronic spontaneous urticaria.

Federal Register

Guide on Nonclinical Safety for Oligonucleotides

Federal Register notice: FDA makes available a draft guidance on nonclinical safety assessments for oligonucleotide drug products.

Human Drugs

Atamyo OKd for Gene Therapy Trial

FDA approves an Atamyo Therapeutics IND for a Phase 1b/2b clinical trial involving its ATA-200 gene therapy for treating rare form of muscular dystrop...

Medical Devices

More Than 1,000 Breakthrough Device Designations

FDA says it has granted breakthrough device designation to 1,041 devices from 2015 through the 9/30 end of the 2024 fiscal year.

Human Drugs

FDA Approves PTC Therapeutics Kebilidi

FDA approves PTC Therapeutics Kibilidi as the first gene therapy to treat aromatic L-amino acid decarboxylase deficiency.

Medical Devices

Home AFib Blood Pressure Monitor De Novo Granted

FDA grants a de novo marketing authorization to Omron Healthcare for its new home blood pressure monitors featuring AI-powered atrial fibrillation det...

Medical Device Recalls Up, Drugs Down: Sedgwick

The Sedgwick third quarter 2024 recall index documents an increase in medical device recalls and a decrease in drug recalls.

Medical Devices

SonoMotion De Novo for Stone Clear Ultrasound

FDA grants SonoMotion a de novo marketing authorization for its Stone Clear device for the ultrasound treatment of post-lithotripsy kidney stone fragm...

Marketing

False or Misleading Xeomin Promotion: FDA

FDA cautions Merz over misleading representations about its Xeomin in a promotional piece featuring celebrity spokesman Nate Berkus.