The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
The timeline extension comes on the heels of the FDA requesting additional information to assess Filspari’s clinical benefit. ・The company submitted responses and the agency determined that the ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on drugs cleared under a new plan to slash FDA drug review times.
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries ...
After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
Investing.com -- Legend Biotech Corp (NASDAQ:LEGN) stock rose 5.7% following the FDA’s release of draft guidance endorsing ...
Management reiterated plans to initiate the REVEAL pivotal trial for TSHA-102, with the first patient dosing scheduled for the current quarter and additional enrollment expected across multiple sites.