Drug Approval | August 12, 2025
Boehringer’s lung cancer medicine gets FDA approval
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
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
Subscribe To Our Newsletter & Stay Updated
