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Nuon Therapeutics, Inc.

Latest From Nuon Therapeutics, Inc.

Sellas Teases Biomarker-Driven Efficacy Of AML Drug With Phase IIa Results

The company remained tight-lipped on the biomarker driving high response rates for its CDK9 inhibitor SLS009 from a Phase II trial, as a Phase III interim analysis for its AML cancer vaccine galinpepimut-S draws near.

Cancer ImmunoOncology

US FDA’s Missed User Fee Goals Spiked In 2023 – And Not Just Because Of COVID-19

CDER missed six goal dates among its 2023 novel approvals, reflecting safety concerns as well as pandemic-related inspection delays; Duchenne muscular dystrophy accelerated approval disagreements caused the biologics center’s lone missed goal.

Pink Sheet Perspectives US FDA Performance Tracker

Deal Watch: Coherus Terminates Immuno-Oncology Alliance With Junshi

Plus deals involving Menarini/VenatoRx, Orion/Glykos, Roche/MOMA, Janssen/Elektrofi, Galapagos/BridGene along with 13 other transactions.

Deal Watch Business Strategies

Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023

AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.

US FDA Performance Tracker Approvals
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    • Nuon Therapeutics Pty. Ltd
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