News 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.
News 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.
News 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.
News 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.
News 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.
News Novo Nordisk rises as Hims & Hers backs down on oral GLP-1 Novo Nordisk's battered stock enjoyed a reprieve after Hims & Hers abandoned plans to launch a compounded version of the new Wegovy pill.
News Lundbeck preps phase 3 for migraine prevention drug Lundbeck seems to have brought its migraine prevention drug bocunebart back on track with positive data for an intravenous formulation.
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