This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis
Alembic receives EIR from USFDA for facility at Panelav
NouvNeu001 is the world’s first allogeneic iPSC-derived cell therapy for Parkinson’s disease to receive this designation
Sun Pharma's Halol plant gets OAI classification from US FDA inspection
Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development
Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product
The U.S. FDA issued a Form 483 with five observations
Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes
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