Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations
The move signals a major expansion in access to next-generation weight-loss therapies
The facility integrates advanced scientific infrastructure and specialised workflows to support complex drug delivery systems, sterile injectables, and differentiated dosage forms
Following the completion of the acquisition on June 3, Noctrix’s flagship product, Nidra will become part of ResMed’s broader sleep medicine portfolio
DCGI-approved semaglutide syringes for diabetes and obesity expand treatment choices and improve affordability
The companies say the drug has now demonstrated clinical benefit in three separate Phase 3 trials
The transaction includes an upfront payment of $1.55 billion, along with up to $1.1 billion in regulatory and commercial milestone payments
Accreditations for Bhayla manufacturing site strengthen the company’s global quality credentials and support expansion of its hormone portfolio into regulated international markets
First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death
An exploratory overall survival signal also leaned in favor of the combination, though the companies noted the result remains preliminary
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