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The FDA has cleared Intellia Therapeutics to resume its MAGNITUDE Phase 3 trial of nexiguran ziclumeran for ATTR cardiomyopathy, five months after a patient death and subsequent clinical hold prompted a safety overhaul.
The FDA has delayed its decision on Eli Lilly's oral obesity pill orforglipron from March 28 to April 10, alongside delays for three other drugs in the new expedited review program.
MagicRNA's mRNA lipid nanoparticle therapy reprogrammed patients' own T cells inside the body, wiping out disease-driving B cells in refractory lupus patients without conventional cell manufacturing.
Petrelintide met its primary endpoint with placebo-like tolerability, but a dose ceiling and a seven-point efficacy gap to Lilly's eloralintide raise questions about its standalone future.
The FDA rejected uniQure's Phase I/II data for AMT-130 and now demands a sham surgery-controlled Phase 3 trial, reversing its own prior guidance and sending shares down 40 percent.
Novocure's Optune Pax uses tumor treating fields to extend survival by two months in locally advanced pancreatic cancer, earning FDA approval through its most rigorous pathway.