The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
Deal brings late-stage lung cancer candidates zidesamtinib and neladalkib into GSK’s portfolio
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 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
Subscribe To Our Newsletter & Stay Updated
