News FDA relents and will review Moderna's flu shot The FDA will start a review of Moderna's flu jab mRNA-1010, after refusing to accept the filing last week, with a new "regulatory approach."
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 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 CEPI steps in to fund Moderna's pandemic flu jab Thanks to CEPI, Moderna's H5 bird flu vaccine can start a pivotal trial shelved after funding for the jab was pulled in the US by HHS Sec Kennedy.
News Update: MSD's $9.2bn deal for flu biotech Cidara confirmed MSD has signed a $9.2 billion takeover deal for Cidara that will bolt on a universal flu prevention candidate in phase 3.
News Astellas pays $285m for Audax cancer drug, and other deals Astellas takes an option on a cancer immunotherapy developed by Audax for up to $1.34bn, with Gilead and Teva also adding to their pipelines.
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