When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

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

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.

Capricor Therapeutics plummeted Friday after the FDA rejected its experimental treatment for cardiomyopathy associated with ...

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

Milestone Pharmaceuticals (MIST) stock falls amid a capital raise as FDA agrees to review its resubmitted NDA for heart therapy Cardamyst. Read more here.

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...

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 ...

A new EastEnders guest star has revealed she was previously rejected by the soap 37 years ago. Shazia Mirza appears in today's episode of the BBC soap as Dr Ayub, who is involved in the baby Jimmy ...