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 Hims & Hers copies Novo Nordisk's new Wegovy pill Competition has already arrived for Novo Nordisk's Wegovy pill, as telehealth company Hims & Hers launches a compounded version.
News Recordati gets €10.9bn takeover bid from private equity firm Recordati has received a takeover offer from private equity group CVC that, if completed, would delist it from the Italian stock exchange.
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