Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications
The FDA has granted Priority Review, setting a target decision date of 9 October 2026, potentially accelerating access to a new treatment option for a subset of patients with high-risk colon cancer characterized
The validation confirms the submission is complete, clearing the way for the EMA’s centralized review process to formally evaluate the therapy
Based on the cumulative data from ACHIEVE-1 through ACHIEVE-5, Lilly plans to submit orforglipron for FDA approval for the treatment of type 2 diabetes by the end of the second quarter
Exclusive Asia-Pacific licensing agreement for Bejescin strengthens the company’s nephrology and autoimmune disease portfolio
The filing is backed by Phase III data from the lidERA Breast Cancer study
The companies say the drug has now demonstrated clinical benefit in three separate Phase 3 trials
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
The development comes as stroke remains one of the world’s biggest health threats
But acquisition charges drag earnings into loss
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