It was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months. In interviews, ...
In any review of mifepristone, the FDA will now have to grapple with Judge Otake’s conclusion that the 2023 REMS decision for ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
Developers of biosimilars -- medicines that are near-identical copies of biologic drugs -- will no longer be required to conduct clinical trials to prove effectiveness.
The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...
UniQure said the U.S. Food and Drug Administration no longer agreed that clinical data for the Dutch company's gene therapy for Huntington's disease may be adequate for a marketing application, ...
The Food and Drug Administration’s recent approval of a second generic version of the abortion pill mifepristone has left people on both sides of the reproductive rights fight scrambling to interpret ...
The FDA denied approving DCA to treat a rare disorder called PDCD. The Higbees are urging the agency to reconsider.
The US Food and Drug Administration said Friday that it is taking action to restrict the use of prescription fluoride supplements, following a directive from the government’s Make American Healthy ...
Tiziana Life Sciences is a buy due to its platform optionality and upcoming catalysts that outweigh its dilution risk and ...
Secretary of Health and Human Services Robert F. Kennedy, Jr., recently announced that the U.S. Food and Drug Administration will launch a review of the safety of the abortion pill, mifepristone.
The agency said the move could halve the time it takes for biosimilars to enter the market, drive competition, and reduce ...
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