drug-approval

Novo Nordisk's Awiqli reduces basal insulin injections from 365 to 52 per year, winning FDA approval after a 2024 rejection over manufacturing and safety concerns.

Johnson & Johnson's Icotyde (icotrokinra), a once-daily oral peptide that blocks the IL-23 receptor, became the first targeted oral therapy to match biologic-level skin clearance in moderate-to-severe plaque psoriasis, marking a potential paradigm shift away from injectable treatments.

Takeda's oveporexton, an oral drug that restores the brain chemical missing in narcolepsy type 1, has received FDA priority review after two Phase 3 trials showed it brought patients to near-normal wakefulness and cut cataplexy episodes by more than 80 percent.

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.

Japan's health ministry has conditionally approved two iPS cell-derived drugs, marking the first time regenerative medicines built from induced pluripotent stem cells will reach patients commercially.