The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”
BioAsia 2026 represents a decisive shift toward execution, scale, and global competitiveness, reflecting the rapid evolution of the life sciences ecosystem
Profit before tax jumped 64% to Rs. 226 crore, while the company maintained robust investment in innovation with net R&D spend of Rs. 249 crore
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
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
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