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146 News Found

Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC
Clinical Trials | January 11, 2026

Merck initiates phase 3 trial of calderasib with Keytruda QLEX for NSCLC

KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer


Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy
R&D | January 08, 2026

Takeda & Protagonist submit FDA application for groundbreaking polycythemia vera therapy

The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production


Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy
News | January 08, 2026

Arrowhead Pharmaceuticals gets green light for first-of-its-kind FCS therapy

REDEMPLO is the first and only Health Canada-approved siRNA therapy for FCS


Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug
Clinical Trials | January 08, 2026

Ascletis Pharma gets FDA nod for Phase II diabetes trial of oral GLP-1 drug

The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies


FDA go-ahead to Roche’s one-minute follicular lymphoma therapy
Drug Approval | December 23, 2025

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial


Soligenix publishes promising Phase 2a data for SGX945 in Behcet's Disease
Clinical Trials | December 21, 2025

Soligenix publishes promising Phase 2a data for SGX945 in Behcet's Disease

SGX945 delivered beneficial effects in 7 of 8 patients suffering from painful oral ulcers


AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
News | December 17, 2025

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion


Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease
Clinical Trials | December 17, 2025

Minghui Pharmaceutical gets FDA green light for Phase III trials of its therapy in thyroid eye disease

The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies