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

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

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.

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

Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...

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

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 ...

Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...