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353 News Found

Novartis opens radioligand therapy manufacturing facility in California
News | November 12, 2025

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
Drug Approval | November 12, 2025

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
Clinical Trials | November 10, 2025

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
Drug Approval | October 29, 2025

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
Clinical Trials | October 22, 2025

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
Clinical Trials | October 22, 2025

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
Drug Approval | October 14, 2025

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


Gilead and Kite to transform cancer care with new data at ESMO 2025
Clinical Trials | October 14, 2025

Gilead and Kite to transform cancer care with new data at ESMO 2025

The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy


AbbVie showcases breakthrough ADC hard-to-treat cancers data at ESMO 2025
Clinical Trials | October 14, 2025

AbbVie showcases breakthrough ADC hard-to-treat cancers data at ESMO 2025

New results from telisotuzumab adizutecan (Temab-A) and ABBV-706 demonstrate continued progress in AbbVie's antibody-drug conjugate (ADC) portfolio targeting difficult-to-treat cancers