News CHMP backs Novo's haemophilia A drug Frehemgo Novo has moved a step closer to EU approval of its long-acting haemophilia A therapy, Frehemgo, which could be a future blockbuster.
News FDA unveils framework for its expedited IND pilot The FDA has published the design of its expedited Investigational New Drug pilot, part of a plan to restore US competitiveness in clinical research.
News FDA to decide on Takeda's psoriasis blockbuster hope in Q1 The FDA has started a review of the marketing application for Takeda's TYK2 inhibitor zasocitinib in psoriasis, setting up a decision in mid-March.
R&D Trial complexity is the new normal When operationalised effectively, RBQM can support earlier risk detection and more targeted quality improvement.
News Reviews underway of first drug for rare disease MOGAD Patients with rare autoimmune disease MOGAD could be months away from having a first approved therapy, as the FDA starts a review of Roche's Enspryng.
News FDA starts review of AZ's COPD blockbuster hope The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
News Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer Eli Lilly's imlunestrant (Inluriyo) for breast cancer has received a new FDA approval, in combination with CDK4/6 inhibitor abemaciclib (Verzenio).
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