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

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

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

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.

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 turned away PTC Therapeutics' proposed vatiquinone treatment for the rare, inherited neurodegenerative disorder Friedreich's ataxia over concerns about the ...

The FDA reviews odronextamab's application for relapsed lymphoma, highlighting trial enrollment issues but confirming safety and efficacy.

Tuesday evening, Regeneron announced that it had received a complete response letter from the FDA regarding its Biologics License Application for linvoseltamab, citing issues at a third-party ...

The FDA said it released the complete response letters (CRLs) on Thursday morning as part of an effort to “modernize and increase transparency” at the agency. We’ve typically had to rely on ...

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