News

US FDA extends review of KalVista's swelling disorder drug due to heavy workload
The U.S. Food and Drug Administration extended the review of KalVista Pharmaceuticals' drug for a type of hereditary swelling ...
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS ...
US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults
The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a ...
US FDA puts on hold Rein Therapeutics' lung disease drug trial
Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...
US FDA approves UroGen's bladder cancer drug
The U.S. Food and Drug Administration on Thursday approved UroGen Pharma's drug to treat a type of bladder cancer, providing ...
Anti-doping watchdog urges US authorities to shut down planned drug-fueled event in Las Vegas
The global watchdog of doping in sports says it will urge public authorities to shut down the drug-fueled Enhanced Games ...
The Manila Times6h
US FDA OKs removal of Mang Tomas, UFC, Jufran from Import Alert 99-45
THE US Food and Drug Administration (US FDA) officially approved Nutriasia's petition to remove Mang Tomas All Purpose Sauce, ...
The FDA Wants AI To Speed Up Health Care Decisions — Here's Why Experts Are Concerned
A new article in the Journal of the American Medical Association said the FDA will implement AI into multiple processes.
MIT Technology Review13h
Here’s what food and drug regulation might look like under the Trump administration
Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on ...
Futurism on MSN8h
The FDA Is Already Outsourcing Drug and Food Analysis to Error-Plagued AI Chatbot
The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...
CNBCTV186h
Syngene's Bengaluru unit passes US FDA test but with VAI classification
The facility can continue selling approved drugs and will also receive approvals for new filings. Shares of Syngene ...