Drug Development

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.

A redesigned CD40 agonist antibody injected into a single tumor triggered body-wide immune responses that eliminated all metastases in two patients, with nearly 200 now enrolled in follow-up trials.

A study of nearly 250,000 U.S. adults finds the shingles vaccine dramatically reduces heart attacks, strokes, and deaths in people with existing cardiovascular disease.

Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, hit all primary and secondary endpoints in the largest-ever dermatomyositis trial, offering the first steroid-sparing treatment for a disease that has lacked targeted therapy for decades.

Tozorakimab becomes the first IL-33-targeting biologic to show statistically significant reductions in COPD exacerbations across two confirmatory Phase 3 trials, after competitors Sanofi and Roche stumbled in the same drug class.

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.

A Japanese research team has identified a small molecule called Mic-628 that advances the mammalian circadian clock by activating the Period1 gene through a previously unexploited molecular pathway, cutting simulated jet lag recovery from seven days to four in mice after a single oral dose.

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.

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.

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.

Two Phase 3 ARTISTRY trials show bictegravir/lenacapavir maintains viral suppression while replacing regimens of up to 11 daily pills with one tablet.