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 AstraZeneca raises guidance on stellar cancer drugs growth AZ reports strong financial results for 2025, and provides a first peek at the data for its oral GLP-1 contender elecoglipron.
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 Lupin settles Myrbetriq patent spat with Astellas for $90m Lupin will be able to keep its generic of Astellas' overactive bladder therapy Myrbetriq on the US market, after reaching a settlement agreement.
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 FDA issues warning letters to five unapproved GLP-1 websites In a handful of strongly-worded warning letters, the FDA is cracking down on sales of unapproved peptides - even if they're labelled for research.
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