FDA Related News

Human Drugs

Migraine Drug Development Guidance

FDA publishes a draft guidance on the clinical development of drugs to prevent migraine.

Human Drugs

AstraZeneca Ends Brazikumab Development

AstraZeneca says it is ending its brazikumab development program that was being studied for Crohns disease and ulcerative colitis.

Human Drugs

FDA Warning on Unapproved Molluscum Treatments

FDA issues a warning against using unapproved products that claim to treat molluscum.

Balance AI Optimism and Pessimism: Califf

FDA commissioner Robert Califf says he sees value in artificial intelligence and agrees that its important to also look at the risk of harm that can b...

Human Drugs

Roche/Genentech Suggestions for nAMD Guidance

Roche/Genentech make suggestions for clarification and improvement to an FDA draft guidance on developing treatments for neovascular age-related macul...

Medical Devices

Patient Access to At-Home Technologies

CDRH asks for public comment on eight questions about using medical technologies in a home setting.

Human Drugs

Doc Bought Oncology Meds to Sell for Profit: DoJ

A New Jersey oncologist becomes the third doctor to plead guilty to participating in a scheme to purchase prescription oncology drugs under false pret...

Medical Devices

FDA Clears Ezra Flash AI for MRI Quality

FDA clears an Ezra 510(k) for its artificial intelligence-enabled Ezra Flash and its use in enhancing MR image quality.

FDA General

CDER Drug Policy Guru Heads to Morgan Lewis

CDER Office of New Drug Policy director Maarika Kimbrell leaves the agency to re-enter private legal practice at Morgan Lewis as a partner resident.

Human Drugs

Clinical Hold on PepGen IND Application

FDA places a clinical hold on a PepGen IND application for a Phase 1 trial of PGN-EDODM1 to treat myotonic dystrophy Type 1.