The decision secures legal protection in China for semaglutide, the blockbuster drug underpinning Novo Nordisk’s diabetes and obesity treatments
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The study will run across 18 sites and enroll roughly 200 patients over 24 months
The acquisition adds HLD-0915, a once-daily oral therapy for prostate cancer, to Johnson & Johnson’s nearly 20-year legacy of innovation in the disease
Applications include detailed scientific rationale and supporting clinical evidence
Experts warn that illegal products may be fake, contaminated, incorrectly dosed, or contain powerful unlisted ingredients
Under his leadership, Chidamide became China’s first original small-molecule anti-tumor innovative drug and the country’s first pharmaceutical product globally licensed out
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy
Subscribe To Our Newsletter & Stay Updated
