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Human Drugs

Black Box Warning Added to Pfizers Xeljanz

FDA approves a Black Boxed warning about an increased risk of blood clots and death with Pfizers tofacitinib (Xeljanz, Xeljanz XR) 10 mg twice daily d...

Medical Devices

MiRus Cygnus Anterior Cervical Plate System Cleared

FDA clears a MiRus 510(k) for the Cygnus Anterior Cervical Plate System.

Human Drugs

Breakthrough Status for Arginase 1 Deficiency Candidate

FDA grants Aeglea BioTherapeutics a breakthrough therapy designation for pegzilarginase, indicated for treating Arginase 1 Deficiency.

Human Drugs

Resonea Sleep Apnea Pre-screener Cleared

FDA clears a Resonea 510(k) for the Drowzle Sleep Apnea Pre-screening Device.

Federal Register

Info Collection on Device Export Approval Letters

Federal Register notice: FDA sends to OMB an information collection extension for Export of Medical Devices; Foreign Letters of Approval.

Human Drugs

6 Observations in QuVa Pharma Inspection

FDA releases the FDA-483 with six observations issued following an inspection at the QuVa Pharma outsourcing facility.

FDA General

House Committee Seeks FDA Answers on Cell Products

House Energy and Commerce Committee leaders ask FDA to explain its slower than expected progress with manufacturers and providers of stem cell product...

Human Drugs

Opdivo CheckMate Trial Misses Endpoint

Bristol-Myers Squibb says a Phase 3 trial of its Opdivo failed to meet the primary clinical endpoint in specified lung cancer patients.

Medical Devices

Metal Expandable Biliary Stent Guidance

FDA finalizes an updated guidance on 510(k) submissions for metal expandable biliary stents.

Federal Register

FDA Sets Generic Drug User Fee Rates

Federal Register notice: FDA sets the generic drug user fee rates for fiscal year 2020.