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Merck and Daiichi Sankyo have voluntarily withdrawn the U.S. Biologics License Application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after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.
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.
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.
The FDA has approved a label update cutting Amgen IMDELLTRA monitoring time for the first two doses from 22-24 hours to 6-8 hours, a change aimed at easing treatment burden for ES-SCLC patients in community oncology settings.
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.
Roche’s collaborator MediLink reported phase III TAISHAN-302 data showing Tam-Peli (tambotatug pelitecan) reduced the risk of death by 54% versus topotecan in Chinese patients with relapsed small-cell lung cancer, meeting its primary endpoint with a favorable safety profile.
GSK’s B7-H3-targeted ADC Ris-Rez cut the risk of death by 54% versus topotecan in the Phase III ARTEMIS-008 trial in relapsed small cell lung cancer in China, with a median overall survival of 18.5 months and fewer severe side effects than chemotherapy.
