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 ...
Breakthrough drug helps rare obesity condition. Other research uncertain amid cuts.
A new drug is helping families who've spent years padlocking fridges, chaining garbage cans, and hiding food as their ...
MIT Technology Review3d
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 ...
Futurism on MSN2d
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." ...
The Financial Express6h
Compliance review: US FDA issues 8 observations for Sun Pharma’s Halol plant following GMP inspection
Sun Pharma said the US FDA issued a Form-483 with eight observations after inspecting its Halol facility from June 2–13.
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 ...
Decrypt13d
US Food and Drug Administration Launches AI Platform to 'Modernize' Agency
The U.S. Food and Drug Administration has rolled out a new AI assistant, Elsa, that it says will increase efficiency at its ...
Sun Pharma shares in focus following eight observations from US FDA, UBS maintains 'buy' call
Sun Pharma bagged eight observations from the US-based regulatory agency US FDA, following an observation at its Halol plant ...
US FDA Pauses Gilead Trials Testing Experimental HIV Pill Combination
(Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in ...