Drug Approval | September 02, 2025
FDA approves Sanofi’s BTK inhibitor for immune thrombocytopenia
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
ITP is a disease of complex immune dysregulation leading to low platelet counts, bleeding, and reduced quality of life
Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
This product is an oral SYK inhibitor and suppresses platelet destruction by macrophages and platelet depletion
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
For the first-line treatment of certain patients with metastatic non-small cell lung cancer
The new tests can support clinical decision making when prescribing direct oral anticoagulants for stroke prevention
This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
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