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9359 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)


Epigenica launches EpiFinder Analysis Service to accelerate Epigenomic research
R&D | February 04, 2026

Epigenica launches EpiFinder Analysis Service to accelerate Epigenomic research

The new service delivers end-to-end support, managing every stage of an epigenomics project


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


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


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


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


SPARC announces receipt of priority review voucher associated with Sezaby approval
News | February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases


Lupin & TB Alliance team up to push groundbreaking TB drug forward
News | February 03, 2026

Lupin & TB Alliance team up to push groundbreaking TB drug forward

TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide