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Human Drugs

Merck Disappointing Data with Keytruda/Yervoy Combo

Merck says Phase 3 data from the KEYNOTE-598 study evaluating Keytruda (pembrolizumab) in combination with Bristol-Myers Squibbs Yervoy (ipilimumab) c...

Biologics

Biogen sBLA OKd for Plegridy Intramuscular Injection

FDA approves a Biogen supplemental BLA for an intramuscular injection route of administration for Plegridy (peginterferon beta-1a), indicated for trea...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 1/29/2021.

Biologics

Janssen, Novavax Report Positive Covid Vaccine Data

Janssen and Novavax report positive data from Phase 3 clinical trials involving each of their investigational Covid-19 vaccines.

Biologics

Biogen Alzheimers BLA Review Extended

FDA extends by three months the review of a Biogen BLA for aducanumab, indicated for treating Alzheimers disease.

Medical Devices

Medtronic PMA OKd for DiamondTemp Ablation

FDA approves a Medtronic PMA for the DiamondTemp Ablation system for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation who ...

Medical Devices

Class 1 Recall of Penumbra Jet 7 Xtra Flex catheter

FDA classifies as Class 1 a Penumbra recall of its Jet 7 Xtra Flex catheter due to its potentially becoming susceptible to distal tip damage during us...

Human Drugs

FDA Clears Vertex IND for Diabetes Therapy

FDA clears a Vertex Pharmaceuticals IND to proceed with a clinical trial for VX-880, an investigational cell therapy for treating Type 1 diabetes.

Human Drugs

Ascentage Pharma Orphan Status for Follicular Lymphoma

FDA grants Ascentage Pharma an orphan drug designation for its novel Bcl-2 inhibitor, APG-2575, for treating patients with follicular lymphoma.

FY 2021 First Quarter OPDP Metrics Released

The CDER Office of Prescription Drug Promotion releases performance metrics on three measures for the first quarter of the current fiscal year.