News Moderna closes on EU approval for combined flu/COVID jab Moderna's combined vaccine for both flu and COVID-19 has been recommended for approval in the EU, after being knocked back in the US.
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 NHS "isn't delivering equitable care for rare diseases" A Genetic Alliance UK report claims the NHS is failing to meet the needs of many of the 3.5 million people in the country who live with rare diseases.
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