FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions

FDA permanently debars former Aegerion Pharmaceuticals sales representative Mark Moffett for his role in padding his sales bonuses by persuading physi...

latest-news-card-1
Federal Register

Final Guide on Compounding Ibuprofen Suspensions

Federal Register notice: FDA releases a final guidance entitled Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Feder...

latest-news-card-1
Medical Devices

Cardiosave Intra-Aortic Balloon Pumps Recalled

Datascope/Getinge recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to the risk of blood entering the devices through a damaged ...

latest-news-card-1
Human Drugs

Improving Myelodysplastic Syndromes Trials

Cancer researchers from FDA and academic medical centers report recommendations from a panel of experts convened to find ways to improve drug developm...

latest-news-card-1
Human Drugs

FDA Lifts Hold on Inhibikase Parkinsons Trial

FDA lifts its clinical hold on an Inhibikase trial of its IkT 148-009 in Parkinsons disease.

latest-news-card-1
Human Drugs

BsUFA Regulatory Research Roadmap

FDA issues a BsUFA 3 regulatory science research roadmap highlighting areas where pilot demonstration projects could improve science-based recommendat...

Human Drugs

FDA/Aetion Oncology RWD Research

The FDA Oncology Center of Excellence and Aetion open a five-year collaboration to research oncology real-world evidence sources.

latest-news-card-1
Human Drugs

GenBioPro Sues to Overturn WV Abortion Pill Law

The manufacturer of the abortion pill mifepristone sues West Virginia over the states law that effectively bans using the drug for its FDA-approved in...

latest-news-card-1
Human Drugs

Merck Ending Keytruda Phase 3 Prostate Cancer Trial

Merck terminates a Phase 3 trial of its Keytruda with other drugs as a treatment for some prostate cancers after an interim data review showed it miss...

latest-news-card-1
Human Drugs

Panel Votes to Approve Cidaras Rezafungin

An FDA advisory committee votes 14 to 1 to recommend that a Cidara Therapeutics NDA for rezafungin demonstrated a favorable benefit-risk profile in tr...