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 Vaccination fall costs UK its measles elimination status The UK has lost its measles elimination status, according to the WHO, due to a spike in cases in 2024 and a fall in vaccination coverage.
News FDA seeks changes to GLP-1, flu shot labels The FDA has asked manufacturers of GLP-1 drugs used for weight loss to remove warnings of suicidal thinking, but added warnings to flu shots.
News Bayer's Monsanto sues mRNA COVID-19 vaccine makers Lawsuits filed by Bayer in the US are seeking damages and royalties on sales of COVID-19 shots sold by Pfizer/BioNTech, Moderna, and J&J.
News CDC cuts recommended childhood jabs from 17 to 11 The CDC has upended the childhood vaccination schedule, cutting the number of recommended shots in a move that has dismayed medical organisations.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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