Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...
Clene is planning to submit an application to the FDA in early 2026 requesting the accelerated approval of CNM-Au8 for ALS.
The FDA launched a more accessible dashboard for its adverse event reporting system, the database that contains medication errors and product quality complaints, the agency said Sept. 28. The FDA ...
Onasemnogene abeparvovec-brve is the first gene replacement therapy approved for SMA patients aged 2 years and older, expanding access beyond infants. Phase 3 trials demonstrated significant motor ...
Agentic AI can help FDA staff manage meetings, conduct pre-market reviews and validate reports, among other tasks, though the ...
The top vaccine regulator at the Food and Drug Administration (FDA) wants to impose vague but sweeping new standards on ...
The Food and Drug Administration (FDA) has issued a statement, published electronically in the New England Journal of Medicine (NEJM) on November ...
Jaguar’s requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia® A ...
The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies ...
FDA is reviewing a new diabetes pill and oral Ozempic alternatives, raising questions about safety, access, pricing ...
WASHINGTON (AP) — Shortly before he was forced to resign, the nation’s top vaccine regulator says he refused to grant Health Secretary Robert F. Kennedy Jr.’s team unrestricted access to a tightly ...
The U.S. Food and Drug Administration is changing its policy on who should get COVID-19 shots, potentially limiting access to new vaccine formulations as they enter the market. New and updated jabs ...
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