Daiichi Sankyo launches first-in-human trial of innovative cancer therapy

The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events

Novartis opens radioligand therapy facility in Carlsbad, US

Novartis is the only pharmaceutical company with a dedicated commercial RLT portfolio

Novartis opens radioligand therapy manufacturing facility in California

New site expands manufacturing footprint to meet future demand; ensures continued on-time delivery rate of >99.9% to patients across western US, Alaska and Hawaii

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition

Relmada gains FDA backing for two registrational trials and reports 92% response with NDV-01 in bladder Cancer

Relmada expects to initiate its Phase 3 program in the first half of 2026

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability

Johnson & Johnson’s Rybrevant shows 45% response rate in HNSCC

Based on these promising results, Johnson & Johnson plans to move the program into a Phase 3 trial to further investigate subcutaneous amivantamab

KEYTRUDA + LENVIMA shows durable 5-year survival benefit in advanced endometrial cancer

The combination is approved for advanced endometrial carcinoma that is pMMR or not MSI-H and has progressed after prior systemic therapy

FDA approves AbbVie’s Upadacitinib for treatment of inflammatory bowel disease

Updated indication expands treatment options for patients with ulcerative colitis and Crohn’s disease when tumor necrosis factor (TNF) blockers are clinically inadvisable

Bristol Myers Squibb showcases transformative advances across oncology portfolio at ESMO 2025