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Zydus Gets USFDA Tentative Nod for Dapagliflozin Tablets
Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for dapagliflozin tablets in 5 mg and 10 mg strengths, paving the way for the company’s entry into the US market subject to final approval.
Angitia Biopharmaceuticals Bags USD 130 Million in Series D Capital Raise
Angitia Biopharmaceuticals has raised USD 130 million in a Series D financing round co-led by Frazier Life Sciences and Venrock Healthcare Capital Partners. The funds will be used to advance the clinical development of lead programmes AGA2118, AGA2115, AGA111 and other pipeline assets.
Industry Study Calls for Faster Adoption of Non-Animal Methods in Pharma R&D
A new multi-stakeholder report led by Dr. Reddy’s Laboratories, Humane World for Animals India, and DBT BRiC – Institute for Stem Cell Science and Regenerative Medicine (InStem) highlights how science-driven, non-animal testing methods could reshape drug development in India.
Sun Pharma to Invest Rs 500 Crore in Expansion of Assam Manufacturing Unit
Sun Pharmaceutical Industries said it will invest Rs 500 crore to expand its manufacturing facility in Assam, aiming to strengthen its domestic production infrastructure and support future growth.
Alvotech Announces Positive Results from Pharmacokinetic Study for Entyvio
Alvotech has reported positive top-line results from a pivotal pharmacokinetic study of AVT80, its proposed biosimilar to Entyvio. The study met all primary endpoints, demonstrating comparable pharmacokinetics, safety, tolerability and immunogenicity to the reference product in healthy adult participants.
Entod Pharmaceuticals Backs Global Push to Prevent Childhood Blindness at UK House of Lords
Entod Pharmaceuticals representatives participate in global discussions at the UK House of Lords to advance prevention-led strategies against childhood blindness, with a focus on ROP screening in India.
Lupin Launches Topiramate Extended-Release Capsules in US Following FDA Approval
Lupin rolls out FDA-approved generic topiramate extended-release capsules in the US for epilepsy and migraine treatment.
Nanox Secures US FDA Clearance for TAP2D Image Enhancement Software for ARC Systems
FDA grants 510(k) clearance to Nanox’s cloud-enabled TAP2D software, enabling 2D image generation from a single tomosynthesis scan and advancing its strategy to position ARC systems as primary diagnostic solutions.
Slingshot Biosciences to Expand into UK and EU Markets
Slingshot Biosciences is expanding its operations into the United Kingdom and European Union to scale deployment of its precision-engineered synthetic cell mimic technology and accelerate cell and gene therapy as well as broader pharmaceutical development.
Japan Patent Boosts Marvel's Neurology Pipeline for MB-204
Marvel Biosciences Corporation, through its subsidiary Marvel Biotechnology Inc., has secured a key intellectual property milestone after the Japan Patent Office granted a patent covering its lead therapeutic candidate, MB-204.
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