Drug Approval | November 21, 2025
AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
Revenue increased 11.4 per cent to Rs. 8,545 crore
For the full financial year FY25, revenue from operations grew 9 per cent to Rs. 11,537.8 crore, compared to Rs. 10,588 crore in FY24.
Multiple studies show the combination potential of vedotin antibody-drug conjugates (ADCs) with pembrolizumab, including the first Phase 1 data in thoracic cancers for two first-in-class ADCs
Blenrep combinations could redefine treatment as early as first relapse where more effective options are needed
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone
Third Phase 3 trial in third type of lymphoma to show improvement in overall survival with an ADCETRIS-containing regimen
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
Sarclisa added to bortezomib, lenalidomide and dexamethasone (VRd) significantly reduced the risk of disease progression or death compared with VRd alone
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