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
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
Based on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one year
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
DOVBLERON marks the 13th addition to Innovent’s commercial portfolio
In 2020, CORXEL acquired the rights to develop and commercialize aficamten in Greater China
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse
Statistically significant and clinically meaningful reduction in the risk of death seen with Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) versus daratumumab plus BorDex
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