Liabooks Home|PRISM News
PRISM

#FDA

Total 3 articles

BioMarin's Hemophilia A Gene Therapy Roctavian Nears Finish Line in U.S. and Europe
TechEN
BioMarin's Hemophilia A Gene Therapy Roctavian Nears Finish Line in U.S. and Europe

BioMarin's gene therapy, Roctavian, is moving closer to approval. The company has resubmitted its application to the U.S. FDA and received a positive opinion from the EMA's CHMP for severe hemophilia A.

FDA Approves First-Ever Pill Version of Blockbuster Weight-Loss Drug Wegovy
TechEN
FDA Approves First-Ever Pill Version of Blockbuster Weight-Loss Drug Wegovy

The US FDA has approved the first-ever pill form of Novo Nordisk's blockbuster weight-loss drug, Wegovy. Showing comparable results to the injection in trials, the daily pill is set to launch in January 2026.

FDA Approves Wegovy Pill, Igniting New Front in Billion-Dollar Weight-Loss Drug Race
TechEN
FDA Approves Wegovy Pill, Igniting New Front in Billion-Dollar Weight-Loss Drug Race

The FDA has approved a once-daily pill version of Novo Nordisk's blockbuster weight-loss drug Wegovy, offering a new option versus the weekly shot and escalating competition with Eli Lilly.