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Latest From Imunon, Inc.
Dizal Scores First JAK1 Approval For Advanced PTCL
China's Dizal has won the first approval worldwide, in its home market, for a JAK1 inhibitor in relapsed/refractory peripheral T-cell lymphoma (PTCL), based on a pivotal Phase II trial. The biotech is also planning a Phase III study with the molecule for second-line PTCL.
CAR-T Therapies: Access Considerations May Influence US FDA's Efficacy Evaluation
CBER's Lola Fashoyin-Aje offers some thoughts on when and how the FDA might consider the accessibility of a product in its approval decisions at BIO 2024.
US Health And Wellness People News: CHPA, Bayer, Viatris, Qnovia, Powerade
Sanofi consumer health scientific affairs lead moves to CHPA; change in Bayer’s US consumer health marketing helm; Viatris CCO moves from same post at Moderna; Qnovia expands scientific advisory board; and Powerade powers Girls Inc. scholarships, programs.
Endo Slams FDA’s ‘Improper Rationalization’ In Adrenalin Rival’s ‘Unlawful Approval’
Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.
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Pharmaceuticals
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Biotechnology
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- Egen, Inc.
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