News | February 04, 2026
FDA launches PreCheck program to bring drug manufacturing back to US
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
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
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
Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics
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
The Union Budget 2026–27 accords strong priority to the upgradation and expansion of healthcare infrastructure and medical education
The Union Budget makes a clear and timely choice by placing biopharma at the centre of India’s next manufacturing wave
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