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.”
The acquisition brings Lilly a novel in vivo cell therapy platform built around engineered circular RNA and proprietary lipid nanoparticles
The approved scheme will deliver around 1 million sq ft of state-of-the-art laboratory and research space across a 12-acre site
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
The upcoming Phase I trial will test the safety, tolerability, and pharmacokinetics of ISM8969 in healthy volunteers and determine the optimal dosing for future studies
The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity
Lupin’s double ‘A’ rating in Climate and Water exemplifies its steadfast commitment to sustainability
This marks the second indication for which gumokimab has gained NDA review acceptance
The Phase 1 single and multiple ascending dose study is set to begin dosing in early Q1 2026
Stevens succeeds Milton Boyer, who has stepped down as CEO but will remain closely involved with the business as an independent member of Kindeva’s Board of Directors
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