FDA Related News

Human Drugs

NIH Ends Mpox Study Early

The National Institutes of Health ends a trial of an mpox antiviral drug that failed to produce an efficacy signal.

Federal Register

FDA Revokes EUAs for B.Braun Covid Devices

Federal Register notice: FDA announces the revocation of B. Braun Medical emergency use authorizations for three Covid-related devices.

Regulating AI in Healthcare: Paragon White Paper

A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds on existing FDA regul...

Human Drugs

NeuroSense Gets FDA Agreement for ALS Study

Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for treating amyotrophic lat...

Human Drugs

Carvykti Shows Favorable Minimal Residual Disease Data

Johnson & Johnson reports data from its Phase 3 CARTITUDE-4 study that show Carvykti significantly increased minimal residual disease (MRD) negativity...

Human Drugs

OCI Case Nets 2 on HIV, Covid Drug Convictions

Two men are convicted of securities fraud in a case involving misrepresented submissions to FDA for a drug purportedly intended to treat HIV and Covid...

Human Drugs

CGMP Violations at Chinas Guangzhou Four Es

FDA warns Chinas Guangzhou Four Es Scientific Co. about CGMP violations in its production of finished drugs.

Medical Devices

Getinge/Maquet Recalls VasoView HemoPro 2

Getinge/Maquet issues a Class 1 recall (device correction) to inform users about important safety information for its VasoView HemoPro 2 Endoscopic Ve...

Biologics

FDA Stem Cell Regulation Court Ruling Analyzed

Four Ropes & Gray attorneys analyze a 9th Circuit Appeals Court decision backing FDA regulation of stem cell products and raise the possibility of fut...