Novo: FREHEMGO Haemophilia A Prophylaxis Wins Positive CHMP Opinion for EU Approval
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.
Clinical Trial Failures 2026: AstraZeneca, Novartis and Kyowa Kirin Report a Wave of Phase 2 and Phase 3 Setbacks
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.
Charles River Laboratories Accelerates Drug Development with Charles River Rapid Cell Banking Platform
Charles River Laboratories launches its NGS-enabled rapid cell banking platform, cutting production timelines by 40% through automated rapid microbiological testing and in vitro characterization.
Gilead Accelerates Global Access Strategy for Gilead Once-Yearly Lenacapavir in HIV Prevention Push
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.
Novo – Anthropic Claude Science Partnership Targets Faster Drug Discovery
Novo and Anthropic announced a September 16, 2026 collaboration pairing Claude Science with Novo’s R&D teams to tackle drug discovery challenges and strengthen AI-driven software engineering, with financial terms undisclosed.
Amgen IMDELLTRA Monitoring Time Cut to 6-8 Hours as FDA Approves Label Update for ES-SCLC
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.
Novo Nordisk Rebrand: Company Unveils ‘Novo’ Name and ‘Lasting Health Starts Now’ Platform
The Novo Nordisk rebrand introduces the single ‘Novo’ brand name, a ‘Lasting Health Starts Now’ platform, and a new culture framework called The Novo Way, unveiled by CEO Mike Doustdar ahead of the company’s 21 September Capital Markets Day in London.
Johnson & Johnson RYBREVANT Amivantamab NSCLC Regimen Delivers Longest Reported Survival in EGFR Exon 20 Lung Cancer
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.
AstraZeneca Enhertu DESTINY-Lung04 Trial Demonstrates 14.3-Month Median PFS in First-Line HER2-Mutant NSCLC
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.
Roche Tam-Peli SCLC Data Show 54% Reduction in Death Risk in Phase III TAISHAN-302 Trial
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.