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news.CHMP endorses Pfizer-BioNTech’s updated Covid-19 vaccine
This updated vaccine is aimed at individuals aged six months and older. The CHMP’s endorsement is based on a comprehensive body of evidence, including clinical, non-clinical, and real-world
This updated vaccine is aimed at individuals aged six months and older. The CHMP’s endorsement is based on a comprehensive body of evidence, including clinical, non-clinical, and real-world
Tyzavan is indicated for the treatment of several serious infections in adults and children one month and above, including septicemia, infective endocarditis, skin and skin structure infections, bone
This sBLA seeks to update the US product label reflecting the results from the Phase III ZENITH trial. Winrevair was initially approved in 2024 to treat adult people
Mazdutide is a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist. The therapy’s unique dual mechanism not only promotes weight loss but also targets visceral fat and enhances metabolic
ALX2004 has been designed using the company’s topoisomerase I inhibitor payload platform to enhance anti-tumour activity and improve patient outcomes in EGFR-expressing tumours. The molecule, developed entirely within
The FDA’s approval adds to its five prior approvals and is based on positive outcomes from the CABINET Phase III trial. CABINET is a multicentre, randomised, double-blinded, placebo-controlled
This condition, caused by genetic mutations in the LEPR gene, leads to disrupted melanocortin-4 receptor (MC4R) signalling, resulting in extreme, constant hunger and severe early-onset obesity. PL7737, an
This rare genetic disease currently lacks FDA-approved treatments, making the submission a significant milestone. Plozasiran, also known as ARO-APOC3, is an investigational RNA interference (RNAi) therapeutic. It aims
Under the agreement, Kaken has secured an option to acquire commercial rights to the antibody in select Asian territories. In return, the company will fund the preclinical and
Under the terms of the agreement, TerSera will pay MacroGenics $40m upon closing. MacroGenics is also eligible for up to $35m in additional sales milestone payments. The transaction