Fda Approves

• The FDA granted approval on April 7, 2026, to Moderna's mRESVIA vaccine, an mRNA-based shot targeting respiratory syncytial virus (RSV) for adults aged 60 and older. • Clinical trials showed 83.7% efficacy against RSV lower respiratory tract disease in the first season, with data from over 37,000 participants across 22 countries including US sites. • This marks the second mRNA RSV vaccine approved after GSK's Arexvy, aiming to reduce 140,000-160,000 annual US hospitalizations among seniors; CDC review expected soon.

• The FDA granted accelerated approval to a novel immunotherapy combination for metastatic pancreatic cancer on March 21, 2026, based on Phase 2 trial data showing a 35% response rate. • The drug combination demonstrated a median overall survival of 14.2 months compared to 11.8 months with standard chemotherapy in the clinical trial of 280 patients. • Pancreatic cancer remains one of the deadliest cancers with a five-year survival rate below 12%, making this approval potentially significant for the estimated 64,000 Americans diagnosed annually.

• The FDA approved the first RSV vaccine for infants via maternal immunization on March 18, 2026, allowing pregnant women to receive vaccination in the third trimester to confer passive immunity to newborns. • The approval is based on a Phase 3 trial showing 82% efficacy in preventing severe RSV disease in infants under six months, with passive immunity lasting approximately three months post-birth. • RSV causes approximately 100,000 hospitalizations and 300-400 deaths annually among US infants, making this vaccine potentially transformative for preventing severe respiratory illness in the most vulnerable population.