The US Food and Drug Administration is starting to publish letters the agency sent to pharmaceutical companies when their ...

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to ...

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

RFK Jr. cancels U.S. Preventive Services Task Force meeting; the Department of Health and Human Services backtracked on its claim that it would release ethics forms for new members of the Advisory ...

Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.

A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...

FDA rejection of MDMA-assisted therapy rattles advocates but doesn’t spell end of psychedelics in medicine, experts say By Deidre McPhillips and Carma Hassan , CNN 8 minute read ...