Biotech | November 26, 2024
FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR
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
The inspection concluded with the issuance of a form 483 with five observations
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