fda

The FDA cited Novo Nordisk for serious violations of adverse event reporting requirements after a 2025 inspection found the company failed to report three patient deaths linked to semaglutide, including one suicide, and lacked adequate procedures for post-marketing drug safety surveillance.

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.

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.

Beam Therapeutics' BEAM-302 has achieved the first-ever in-vivo base editing correction of a disease-causing mutation in human patients, reaching therapeutic AAT levels in a Phase 1/2 trial for alpha-1 antitrypsin deficiency. A pivotal Q1 2026 data readout is now imminent.

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.

The FDA's new Plausible Mechanism Pathway enables approval of one-patient gene editing therapies without traditional clinical trials, inspired by the first personalized CRISPR cure for an infant with a fatal metabolic disorder — but ethicists warn of a regulatory Pandora's box.