US EditionPTC Therapeutics Pulls Translarna Bid After FDA Flags Weak Proof - PTC Therapeutics (NASDAQ:PTCT)
PTC Therapeutics ended its decade-long effort after the FDA found Translarna's data insufficient to prove effectiveness in treating nonsense-mutation Duchenne muscular dystrophy.
7 Articles
7 Articles
PTC Therapeutics Ends Bid to Seek FDA Approval for Rare Muscle Disease Drug
PTC Therapeutics said it cannot resolve differences it has with the FDA in interpreting clinical trial data for Translarna, a drug it developed for Duchenne muscular dystrophy. The rare disease drug developer’s decision to withdraw Translarna’s FDA submission comes nearly a year after a negative European regulatory decision for the drug. The post PTC Therapeutics Ends Bid to Seek FDA Approval for Rare Muscle Disease Drug appeared first on MedCit…
PTC Therapeutics Provides Regulatory Update and Withdraws Its New Drug Application for Translarna™
We are disappointed to report that PTC Therapeutics has withdrawn its New Drug Application for Translarna™ (ataluren) for the treatment of nonsense mutation DMD after feedback from the FDA that the data are insufficient to meet the standard for approval. The company is expected to inform the community in the coming weeks of next steps for those currently receiving Ataluren therapy. We are deeply grateful to the families who participated in cli…
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