FDA clears Sora Neuroscience’s brain mapping software
Sora Neuroscience, a brain AI software company, announced it received FDA clearance for its Cirrus brain mapping software, which is ...
Tag: FDA
STAT+: Radical transparency at the FDA, and a pivotal moment for vaccines
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign ...
FDA announces a new priority review program in bid to further administration goals
WASHINGTON — The Food and Drug Administration is launching a program to reward companies with accelerated drug review and speedy agency ...
FDA approval of pembrolizumab marks major shift in head and neck cancer treatment
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ...
FDA approves pembrolizumab for resectable head and neck cancer with PD-L1 expression
Credit: Unsplash/CC0 Public Domain Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) ...
Merck RSV Drug for Infants Wins FDA Nod, But CDC Committee That Will Advise on Its Use is Gutted
A Merck drug developed to prevent disease from respiratory syncytial virus (RSV) in infants has won FDA approval, introducing competition ...
FDA launches AI tool for its employees
The FDA launched Elsa, a generative AI tool designed to help employees, including scientific reviewers and investigators, work more efficiently. In ...
Kura Oncology Drug’s Data at ASCO Support FDA Filing Now Under Priority Review for Leukemia
A Kura Oncology and Kyowa Kirin-partnered drug vying to become the first FDA-approved treatment for cases of acute myeloid leukemia ...
FDA approves a next-generation Covid vaccine from Moderna, with restrictions
The Food and Drug Administration approved Moderna’s new Covid-19 vaccine late Friday, though it placed restrictions on its use that ...
New FDA Covid-19 Policy Supports Vaccines for High-Risk Groups, More Clinical Trials for Others
When Covid-19 vaccines roll out for the fall and winter respiratory illness season, they will continue to be based on ...
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