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The Food and Drug Administration (FDA) yesterday announced that it would ease age requirements for blood donors, and adjust ...
FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety program requirements.
FDA eliminated REMS for six approved CAR-T therapies. Patients no longer need to stay near treatment site for two weeks or avoid driving post-therapy. Market-moving news hits Benzinga Pro first—get a ...
Investing.com - H.C. Wainwright has reiterated a Buy rating and $75.00 price target on Legend Biotech Corp . (NASDAQ: LEGN), which has shown strong momentum with an 8.56% gain over the past week ...
Four states petitioned the Food and Drug Administration on Thursday to lift its lingering restrictions on abortion pills. The attorneys general of California, Massachusetts, New Jersey and New ...
WASHINGTON — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional ...
Many conservatives want the FDA to impose tighter restrictions on mifepristone and misoprostol, which can be delivered by mail. The medication accounted for 63 percent of U.S. abortions in 2023.
Four Democrat-led states ask FDA to remove abortion pill restrictions. The attorneys general of New York, California, Massachusetts and New Jersey asked the FDA to lift some requirements on ...
In its Friday approval letter, the FDA didn’t explain the restrictions although they reflect skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.
Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions -- by its April 1 ...
WASHINGTON (AP) — The Food and Drug Administration has issued a long-awaited approval of Novavax's COVID-19 vaccine but with unusual restrictions.