Agency could revisit contraindications and warnings regarding allergic reactions and anaphylaxis management depending upon what it hears from the MHRA; FDA and Pfizer say there was no signal for severe allergic reactions in the Phase III trial, but advisory committee member Paul Offit suggests a dedicated study is needed.
The US Food and Drug Administration could strengthen currently proposed contraindications and warnings for Pfizer Inc./BioNTech SE’s COVID-19 vaccine based upon what it learns from the UK about two reports there of anaphylactic reactions after inoculation in people with a known history of severe allergies.
At a 10 December meeting of the Vaccines and Related Biological Products Advisory Committee, Marion Gruber, director of the FDA’s...
Pfizer/BioNTech and Moderna rapidly adapted Comirnaty and Spikevax for the 2024-2025 season to address the KP.2 variant after the US FDA had advised them to target JN.1 in June.
The companies said their combination mRNA vaccine showed protection against SARS-CoV-2 and influenza A, but not influenza B.
The UK giant’s COVID-19 prophylactic sipavibart could soon reach Europe and competition is sparse.
When life hands a biotech company the equivalent of good grapes, the expectations are for its products to be the equivalent of fine wine. Before that Moderna looks likely to make lemonade.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
