FDA Related News

Human Drugs

FDA Fast Tracks Arialys ART5803

FDA grants Fast Track designation to Arialys Therapeutics ART5803 to treat anti-NMDA receptor encephalitis.

FDA General

White House Looking at 3 Possible FDA Commissioners: Reports

Referencing a Stat online report, MSN identifies three finalists to replace Marty Makary as FDA commissioner.

Human Drugs

FDA Drug, Biologics Centers Continue Workforce Decline

CDER and CBER continue to experience net workforce losses through the first nine months of fiscal year 2026, although hiring improved during the third...

Human Drugs

AstraZeneca, Ionis' Wainua Misses Phase 3 Study Endpoint

AstraZeneca and Ionis Pharmaceuticals say that their Phase 3 CARDIO-TTRansform trial evaluating Wainua (eplontersen) in patients with transthyretin-me...

Human Drugs

Increase in Drug WLs Shows Structural Problem: Analysis

Krieger Scientific CEO Joseph Morwald says a 59% increase in FDA drug Warning Letters in 2025 over 2024 should be seen by industry as a diagnosis of a...

Human Drugs

Hearing on FDA's Role in Retaining Biomedical Innovation in U.S.

A Capitol Hill hearing next week examines how FDA can help strengthen the nation's leadership in biomedical innovation.

Human Drugs

Petition Asks Committee Review of Anticholinergic Drugs

Two former FDAers petition the agency to appoint an advisory committee to consider whether anticholinergic drugs are associated with an increased risk...

Restore Former Inspection Processes: Gortler

Former FDAer David Gertler says its time for the agency to resume the unannounced, in-person inspections of drug and medical device facilities that ma...

Human Drugs

Catalent Indiana FDA-483 Out

FDA releases the form FDA-483 with eight observations from a reinspection at the Bloomington, IN-based Catalent Indiana sterile drug manufacturing fac...

Human Drugs

Amphastar Subsidiary Gets Warning Letter for California Facility

FDA sends Amphastar Pharmaceuticals subsidiary International Medication Systems a Warning Letter citing current GMP violations at its South El Monte, ...