The FDA accepts Dyne’s BLA with Priority Review for zeleciment rostudirsen in exon 51 skipping DMD, setting a PDUFA target action date of January 21, 2027.
FDA approved zidesamtinib for previously treated ROS1+ locally advanced/metastatic NSCLC, marking GSK’s entry into approved lung cancer therapeutics following acquisition of Nuvalent’s portfolio. ROS1 ...
FDA approval covers post–ROS1 inhibitor locally advanced/metastatic ROS1-positive NSCLC, granted ahead of the September 18, 2026 PDUFA date with breakthrough therapy and orphan drug designations.
The 2026 MLB All-Star Game is just a few short weeks away, with Citizens Bank Park in Philadelphia set to play host to the annual exhibition of baseball's brightest stars. Phase 1 of the fan voting ...
Major League Baseball's All-Star Game is about three weeks away and Phase 1 of voting is over. While fans will still have time to vote for their favorite players, only finalists will be available for ...
As the biotech world flocks to San Diego today for the BIO International Convention, the Department of Health and Human Services has provided plenty of conversation fodder with the announcement of a ...
The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen Elsunersen ...
Retatrutide met primary and key secondary endpoints in a 2339-participant, randomized, double-blind, placebo-controlled phase 3 trial, demonstrating clinically meaningful weight reduction across 4, 9, ...
The US defence department has selected 11 tech firms to build its next generation of low-cost, disposable drones, marking a distinct pivot towards Silicon Valley-style mass production. Last week, the ...
GM1 gangliosidosis, caused by biallelic variants in GLB1, results from deficiency of lysosomal β-galactosidase, which degrades GM1 ganglioside. This fatal neurodegenerative disease currently has no ...
While the legacy of the MCU’s original Avengers is plain to see within the franchise, many of the heroes that formed the team are no longer active in its stories. Additionally, some of Phase 1’s ...