Drug Approval | May 30, 2026
FDA delays AstraZeneca decision on camizestrant as regulators seek more data
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
Across more than 85 abstracts, AstraZeneca will showcase 10 approved medicines and 13 potential new therapies
At the center of the deal is TERN-701, a drug recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for adults with Philadelphia chromosome-positive chronic myeloid leukemia
The twin designations are designed to speed up the development and review of promising medicines targeting serious conditions with high unmet need
The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck
The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis
Otsuka will pay $700 million to Transcend shareholders at closing, with an additional $525 million in contingent payments tied to future sales milestones
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Iza-bren met both dual primary endpoints, delivering statistically significant and clinically meaningful improvements in progression-free survival
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