AbbVie JUVMO (tavapadon) has received FDA approval as the first selective D1/D5 receptor agonist for adults with Parkinson’s disease. AbbVie expects U.S. availability in October 2026.
Merck and Daiichi Sankyo have voluntarily withdrawn the U.S. Biologics License Application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after discussions with the FDA indicated that the submitted data did not meet the requirements for accelerated approval.
New MajesTEC-3 modeling from Johnson & Johnson finds that TECVAYLI plus DARZALEX FASPRO, used as early as second line, could give roughly 87% of relapsed/refractory multiple myeloma patients a mortality risk and life expectancy close to the general population, driven by a 90% drop in disease-progression risk versus standard of care.
Johnson & Johnson has reported pivotal Phase 3 findings for CAPLYTA (lumateperone) in bipolar mania, with the study showing significant and rapid improvement in manic symptoms.
Novo receives a positive CHMP opinion for once-weekly Sogroya® (somapacitan) to treat children with idiopathic short stature in Europe.
Novo has secured a positive CHMP opinion for FREHEMGO® (denecimig) to treat haemophilia A in adults and children, offering the first FVIIIa mimetic with once-monthly, bi-weekly, and weekly dosing options in a pre-filled pen.
Three major drugmakers disclosed missed primary endpoints within days of each other in September 2026 — here’s what went wrong, who it affects, and what it signals about pharma R&D.
Gilead Sciences accelerates global access planning for investigational once-yearly lenacapavir, expanding royalty-free generic licensing across 120 high-incidence countries alongside Phase 3 PURPOSE 365 trials.
Final PAPILLON trial results show Johnson & Johnson’s RYBREVANT (amivantamab-vmjw) plus chemotherapy achieved a 34.3-month median overall survival in EGFR exon 20 insertion-positive NSCLC — the longest reported to date in this historically hard-to-treat population.
Results from the AstraZeneca Enhertu DESTINY-Lung04 Trial show a 37% reduction in risk of disease progression or death, establishing first-line efficacy for T-DXd in HER2-mutant non-small cell lung cancer.
