Drug Approval | May 29, 2025
Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
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 $500m and sales royalties.
Lupin has received US$ 25 million from AbbVie for initiation of Phase 1 clinical studies successfully
EZHARMIA is the fifth innovative oncology medicine to be launched in Japan by Daiichi Sankyo in the past three years
The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke
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