Drug Approval | December 06, 2024
FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
For people with relapsed or refractory diffuse large B-cell lymphoma
For people with relapsed or refractory diffuse large B-cell lymphoma
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR
Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
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