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 recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
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
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
CSPC will receive an upfront $1.2 billion from AstraZeneca for access to eight programmes, AI molecular design capabilities, and the LiquidGel platform
rofitability showed strong momentum, with EBITDA rising 44.9% YoY to Rs. 8,697 million
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