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)
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
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
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
A nationwide network of over 1,000 accredited clinical trial sites will be created to accelerate drug development timelines and enhance research credibility
The Union Budget makes a clear and timely choice by placing biopharma at the centre of India’s next manufacturing wave
The Union Budget 2026–27 accords strong priority to the upgradation and expansion of healthcare infrastructure and medical education
The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options
The state-of-the-art commercial production plant will be built on a 95-acre site in Saarlouis, acquired at the end of 2024
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