FDA Related News

Human Drugs

Zhimeng Bio Gets Orphan Status for ALS Drug

FDA grants Shanghai-based Zhimeng Biopharma an orphan drug designation for its small-molecule KCNQ2/3 selective opener compound (CB03) for treating am...

Medical Devices

Medtronic PMA for Extravascular ICD Approved

FDA approves a Medtronic PMA for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defi...

Human Drugs

Genentechs Rozlytrek Gets Expanded Use

FDA grants Genentech accelerated approval for an expanded use for Rozlytrek (entrectinib) in treating pediatric patients older than one month with sol...

Medical Devices

Fresenius Recalls Some Hemodialysis Machines

Fresenius Medical Care recalls some of its 2008 Series Hemodialysis Machines because patients may be exposed to toxic compounds that leach from some p...

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...

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FDA posts a revised draft guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of ...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