FDA Related News

FDA Approves New Tibsovo Indication

FDA approves a new indication for Servier Pharmaceuticals Tibsovo to treat adults with some myelodysplastic syndromes as detected by an Abbott compani...

Biologics

Complete Response on Dupixent sBLA

FDA sends Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chronic spontaneous urtica...

Medical Devices

Medtronic Warning on McGrath Video Laryngoscopes

FDA posts a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have been offered for sale i...

Human Drugs

Guide on Scientific Info on Unapproved Uses

FDA posts a revised draft guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of ...

Federal Register

Generic Animal Drug User Fee Rates

FDA sets the rates and payment procedures for fiscal year 2024 generic new animal drug program user fees.

Federal Register

FDA Sets Animal Drug User Fee Rates

Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2024 animal drug user fees.

Biologics

FDA Approves Zymfentra as Maintenance Therapy

FDA approves a Celltrion BLA for Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis a...

Human Drugs

Panacea Biotec Gets 9-item FDA-483

FDA issues Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firms Himachal Pradesh, India manufacturing 10/3-12.

Biologics

ImmunityBio Refiles Bladder Cancer BLA

ImmunityBio refiles its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating patients with BCG-unresponsive non-musc...

Human Drugs

Keytruda Positive Data in Cervical Cancer

Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurre...