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Andelyn Biosciences and ENCell Forge Global Manufacturing Alliance
Andelyn Biosciences and ENCell partner to build a cross-continental manufacturing network, enabling faster development and global delivery of advanced gene therapies.
US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation
FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.
Merck Wins FDA Approval for Once-Daily IDVYNSO (Doravirine/Islatravir)
IDVYNSO is approved for adults with virologically suppressed HIV-1 with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
DuPont Launches Liveo Pharma TPE Overmolded Assemblies for Biopharma Processing
DuPont introduces advanced TPE overmolded assemblies to enable safer, more efficient ultrapure fluid transfer in biopharmaceutical manufacturing, reducing contamination risks and operational complexity.
Roche Reports Strong Phase III Results for Fenebrutinib in Multiple Sclerosis
Roche’s investigational drug fenebrutinib shows significant reduction in relapse rates and disease activity in multiple sclerosis, offering potential for improved long-term outcomes in patients.
Amneal Pharmaceuticals to Acquire Kashiv BioSciences to Create Integrated Global Biosimilar Platform
Amneal Pharmaceuticals to buy Kashiv BioSciences, accelerating biosimilar pipeline and strengthening US market position for affordable medicines.
Innovative Lab Services Completes Acquisition of Analytical Instrument Management
Innovative Lab Services acquires Analytical Instrument Management, creating an end-to-end analytical instrument solutions platform.
Supriya Lifescience Receives US FDA EIR with VAI Status for Lote Parshuram Facility
Supriya Lifescience receives US FDA EIR with VAI classification for its Lote Parshuram facility, closing the February 2026 audit inspection cycle.
Zyax Chem Buys 26 Percent Stake in Gaymed Labs
Zyax Chem acquires 26 percent stake in Gaymed Labs, securing board representation and boosting expansion in the ophthalmic segment.
OneSource and Orbicular Receive US FDA Tentative Approval for Generic Semaglutide
OneSource and Orbicular secure US FDA tentative approval for generic semaglutide injection, advancing ANDA filing for Ozempic with manufacturing support from OneSource.
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