News

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 extends review of KalVista's swelling disorder drug due to heavy workload
KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended the review of its drug for a ...
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 ...
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 MSN3d
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." ...
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 ...
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 ...
BioWorld6d
US drug security will come at a price
When it comes to the U.S. biopharma market, pricing seems to be the driving focus of most congressional conversations – and ...
U.S. News & World Report3d
US FDA Extends Review of KalVista's Swelling Disorder Drug Due to Heavy Workload
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 ...