The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
Treatments for are allergic fungal rhinosinusitis, bipolar I disorder, Hunter syndrome, Leber hereditary optic neuropathy, ovarian cancer, and schizophrenia under review.
After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
6don MSN
Legal questions swirl around FDA's new expedited drug program, including who should sign off
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...
A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...
Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite ...
We are grateful for the collaborative feedback from FDA on the Gemini program, which provides us a clear and expedient path forward for seeking approval of Gemini as a treatment for AKI,” said, James ...
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.
Inovio’s upside hinges on INO-3107 for HPV-6/11 RRP with FDA PDUFA Oct 2026, regulatory risk, tight cash, and cheap EV. Check ...
A Type B meeting between the FDA and Plus Therapeutics offered clarity and direction for the next steps in development of ...
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