Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
Shares of Travere Therapeutics (NASDAQ:TVTX) surged 14% Tuesday following the company's announcement of a successful Type C ...
The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food ...
The Trump administration’s freeze on communications from U.S. health agencies is leading to another disruption: the abrupt ...
For the eteplirsen and aducanumab approvals, the FDA made its decision using analyses not included in the drug companies' original analysis plans, the OIG said. In addition, some meetings with ...
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and ...
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today ...
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Moleculin Biotech (MBRX) has received FDA feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 ...
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
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