News

US FDA extends review of KalVista's swelling disorder drug due to heavy workload
By Puyaan Singh (Reuters) -KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended ...
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 ...
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 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 ...
Sun Pharma's Halol plant gets 8 observations from US FDA after latest inspection
According to a regulatory filing by the company, the US FDA conducted a Good Manufacturing Practices (GMP) inspection at the ...
MIT Technology Review1d
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 ...
BusinessMirror13h
OUT OF THE RED | US FDA approves petition to remove Mang Tomas, UFC, Jufran from Import Alert 99-45
The US Food and Drug Administration (US FDA) has officially approved Nutriasia’s petition to remove Mang Tomas All Purpose Sauce, Jufran Banana Sauce, and UFC Banana Sauce (both Regular and Hot ...
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.
Futurism on MSN1d
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." ...
FDA Will Use AI to Approve Drugs and Devices Faster
Learn more about the generative AI technology that will be used at the Food and Drug Administration (FDA) to speed up reviews ...