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 ...
Tag: FDA
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 ...
FDA approves formula for fall COVID vaccines
Visual Generation / iStock The "Make Our Children Healthy Again" report issued yesterday by the Make America Healthy Again (MAHA) ...
FDA advisers recommend Covid vaccine updates to target new strains | US healthcare
The Food and Drug Administration’s advisory committee unanimously recommended that newest vaccines for Covid should be updated to target a ...
FDA vaccine advisers recommend sticking with JN.1 strain for next COVID vaccines
The Food and Drug Administration (FDA) vaccine advisory group today recommended sticking with a monovalent JN.1 lineage vaccine for COVID ...
New FDA Covid vaccine policy raises access, transparency questions
Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon ...
FDA says it will limit access to Covid-19 boosters for Americans under 65 | US news
The Food and Drug Administration (FDA) announced on Tuesday that it will limit access to seasonal Covid-19 boosters for healthy ...
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