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PTC pulls file for Duchenne therapy on FDA feedback
PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.
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FDA says comparator dose scuppered Moderna's flu jab filing
The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine.
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Moderna cries foul as FDA blocks filing of mRNA flu shot
The FDA won't accept Moderna's filing for an mRNA-based flu vaccine, in the latest signal of the changing regulatory climate for vaccines in the US.
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FDA kicks off review of Takeda's narcolepsy hopeful
The FDA has started a priority review of Takeda's oveporexton for sleep disorder narcolepsy, setting up a decision in the third quarter of the year.
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Dismay as FDA blocks Regenxbio's Hunter syndrome therapy
The FDA said it needs more information before it can approve Regenxbio's gene therapy for Hunter syndrome, in a devastating decision for patients.
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