FDA Related News

Human Drugs

Bayer Looking to Expand Nubeqa Indication

Bayer says it will present positive results from a Phase 3 Nubeqa prostate cancer trial to FDA to consider a potential indication expansion for the dr...

Biologics

Priority Review for Atara Gene Therapy

FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating Epstein-Barr virus-...

FDA General

Almost 3,000 Establishment Inspections in FY 2023

The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type and world region.

Human Drugs

GMP Violations in YangZhou Records Review

FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.

Human Drugs

CGMP Violations at Jiangsu Hengrui

FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs

Combination Product Application User Fees

FDA publishes a guidance on how it calculates combination product application user fees.

Human Drugs

FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug

FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control i...

Human Drugs

Guidance on Pediatric IBD Drug Development

FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.

Human Drugs

FDA Wants to Stem Common Chronic Diseases: Califf

FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.

Medical Devices

Smith+Nephew New Hip System Cleared

FDA clears a Smith+Nephew 510(k) for its new Catalystem Primary Hip System.