HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The new service delivers end-to-end support, managing every stage of an epigenomics project
Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics
A nationwide network of over 1,000 accredited clinical trial sites will be created to accelerate drug development timelines and enhance research credibility
The Union Budget makes a clear and timely choice by placing biopharma at the centre of India’s next manufacturing wave
The Union Budget 2026–27 accords strong priority to the upgradation and expansion of healthcare infrastructure and medical education
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