FDA Related News

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.

Biologics

Adaptimmune Therapeutics Plan Lete-Cel BLA

Adaptimmune Therapeutics plans a rolling BLA submission for cell therapy lete-cel in certain people with synovial sarcoma or myxoid/round cell liposar...

Human Drugs

7 Observations on U.S. Specialty FDA-483

FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility in Allentown, PA.

Human Drugs

Oligonucleotide-Based Therapeutic Assessment

FDA publishes a draft guidance on the nonclinical safety assessment of oligonucleotide-based therapeutics.