FDA Related News

Medical Devices

Lifecycle Recommendations for AI-Enabled Devices

FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical device software functions...

Sex Differences in Clinical Evaluations of Products

FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.

Biologics

RSV Vaccines Get Guillain-Barr Warning

FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) and GlaxoSmithKline ...

Human Drugs

FDA OKs Arrays Braftovi for Some Cancers

FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.

Human Drugs

Ionis Spinraza Approved by FDA for SMA

FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.

Human Drugs

FDA OKs Galderma Dermatitis Drug Nemluvio

FDA approves Galdermas Nemluvio to treat some dermatitis patients aged 12 and older.

Human Drugs

Alcon Recalls Systane Ultra PF Eye Drops

FDA says Alcon recalled one lot of Systane Ultra PF eye drops due to potential fungal contamination.

Human Drugs

Guide on Clinical Trials Using Tissue Biopsies

FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.

Human Drugs

Draft Guide on Using AI for Drug Development

FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and B...

Human Drugs

Neumoras Phase 3 Depression Study Misses Endpoints

Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary endpoint and a key seco...