The FDA declined approval of Darzalex Faspro for newly diagnosed, transplant-ineligible multiple myeloma in its current form.

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

PTC Therapeutics (PTCT) announced that the U.S. FDA has issued a Complete Response Letter related to the New Drug Application for vatiquinone for ...

The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...

Today, the FDA issued a complete response letter (CRL) for vatiquinone (PTC Therapeutics), delaying its potential approval as a treatment for Friedreich ataxia amid efficacy concerns.

There are several ways companies handle a complete response letter, ranging from full disclosure to no disclosure. Unfortunately, only 93 of 687 (14%) FDA statements within complete response ...

PTC Therapeutics ( ($PTCT) ) has issued an update. On August 19, 2025, PTC Therapeutics announced that the FDA issued a Complete Response Letter ...