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3865 News Found

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
News | February 05, 2026

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)


FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus
Drug Approval | February 05, 2026

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available


ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer
Clinical Trials | February 04, 2026

ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer

The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy


NATCO receives FDA's tentative approval for Erdafitinib tablets
News | February 04, 2026

NATCO receives FDA's tentative approval for Erdafitinib tablets

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration


Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease
Clinical Trials | February 04, 2026

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs


Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
News | February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway


Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial
Clinical Trials | February 04, 2026

Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial

The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated


China nod to Darolutamide for metastatic hormone-sensitive prostate cancer
News | February 04, 2026

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT