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

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...

On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...

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

Cybin has made steady progress but faces major hurdles, with its stock swayed by sector sentiment. Read why CYBN stock is upgraded to hold.

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

The U.S. Food and Drug Administration (FDA) on Thursday published more than 200 complete response letters ((CRLs)), through ...

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

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...

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.