Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for an enterprise value of approximately US$ 151 million
Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
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
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