FDA Related News

Human Drugs

FDA Reports Gains in Drug Inspection Program

FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong performance under an int...

Human Drugs

Testing Deficiencies Cited at Asahi Kasei Finechem API Plant

FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys active pharmaceutical ...

Human Drugs

Advocacy Groups Press Congress on Biosimilar Legislation

Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-called interchangeable ...

Human Drugs

Sanofi Reports Positive Data for Atopic Dermatitis Drug

Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-stage clinical trials...

Medical Devices

FDA OKs Guardant360 CDx Companion Diagnostic

FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant metastatic colorectal...

FDA Drug Ad Enforcement Letters Hit 25-Year High

Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 2025, noting that the ...

Human Drugs

Corcept Reports Promising Survival Data for Ovarian Cancer Drug

As its NDA is currently under FDA review, Corcept Therapeutics says its experimental drug relacorilant met the overall survival primary endpoint in a ...

Human Drugs

6 Observations in Lupin Nagpur Inspection

FDA releases the form FDA-483 with six observations from an inspection at the Lupin sterile manufacturing facility in Nagpur, India.

Medical Devices

Draft Guide on Blood Pressure Monitoring Sensors

FDA issues a draft guidance detailing expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate...

Medical Devices

Alert on Compromised Wound/Burn Dressings

FDA issues an early alert warning of a potentially high-risk issue involving certain wound and burn dressings made by Integra LifeSciences.