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 ...
FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The FDA expanded its approval of Moderna's RSV vaccine on Thursday to include adults under age 60 at increased risk of the ...
MIT Technology Review2d
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." ...
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 ...
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.
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 ...
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 ...
The Manila Times2d
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, ...
Decrypt12d
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 ...
BusinessMirror1d
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 ...