This verdict could spell the end for Translarna’s decades-long and tumultuous US DMD development journey.

PTC Therapeutics has withdrawn its New Drug Application resubmission for Translarna following feedback from the US Food and Drug Administration. Translarna is an investigational therapy for nonsense ...

With the writing apparently on the wall, PTC Therapeutics has called off its latest bid for FDA approval of its Duchenne muscular dystrophy (DMD) drug Translarna.  | Late Thursday, PTC revealed that ...

PTC Therapeutics announced it will withdraw the ataluren NDA for nmDMD, citing FDA concerns regarding the evidence of the agent's effectiveness.

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that it has withdrawn the New Drug Application (NDA) resubmission for ...

PTC Therapeutics, Inc. PTCT closed lower on Thursday following the company’s decision to withdraw its New Drug Application for Translarna after receiving feedback from the U.S. Food and Drug ...

USA-based rare disease drug developer PTC Therapeutics saw its shares drop 5.2% to $67.05 after market close, when it announced that it has withdrawn the New Drug Application (NDA) resubmission for ...

In a statement, PTC's chief executive, Matthew Klein, said the company had decided to pull the filing for Translarna (ataluren) as a treatment for nonsense mutation DMD after the FDA said it was ...

PTC Therapeutics withdrew a New Drug Application for Translarna, a muscular dystrophy treatment, after the Food and Drug Administration indicated it would likely not grant approval.

Please provide your email address to receive an email when new articles are posted on . PTC Therapeutics Inc. released results showing that treatment with Translarna delayed loss of ambulation by more ...

The European Commission (EC) adopted the opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) not to renew the authorization of PTC Therapeutics, ...

PTC Therapeutics withdrew its New Drug Application (NDA) resubmission for Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy (nmDMD) following feedback from FDA indicating that the ...