GSK eyes up combo approval for previously withdrawn myeloma drug
The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.
25 November 2024
25 November 2024
The US Food and Drug Administration (FDA) is expected to make a Prescription Drug User Fee Act (PDUFA) decision by mid-2025.
Novo Nordisk and Ypsomed’s 2023 deal is rumoured to include an autoinjector supply for potential Wegovy successor CagriSema.
The approval triggers a $500m payment to BridgeBio under a royalty funding agreement.
The request is based on findings from the Phase III ASTRO study, which achieved the primary endpoint of clinical remission at week 12.
The biotech uses its AI platform to discover the therapeutic potential of plant-based molecules, advancing ten candidates with the funds.
TCR immunotherapy is emerging as a promising, targeted approach for treating solid tumours and other indications.
The study compared CARVYKTI's efficacy and safety against standard-of-care regimens in patients with multiple myeloma.
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