Health news
The first generic version of Cuvposa® (glycopyrrolate) Oral Solution has been made available by Endo International. Glycopyrrolate Oral Solution is an anticholinergic indicated to reduce chronic severe drooling in patients 3 to 16 years of…
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol) for the treatment of amyotrophic lateral sclerosis (ALS). AMX0035 is an oral, fixed-dose…
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application for ravulizumab-cwvz in adults with generalized myasthenia gravis (gMG). The application is supported by data from a global, multicenter,…
The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application for elivaldogene autotemcel (eli-cel) for the treatment of cerebral adrenoleukodystrophy in patients less than 18 years of age without a…
A phase 3 study evaluating a novel fixed-dose combination of extended release (ER) formulations of pramipexole and rasagiline (P2B001) in adults with early Parkinson disease met its primary and key secondary endpoints. The 12-week, multinational,…
The Food and Drug Administration (FDA) has accepted the Biologics License Application for ublituximab for the treatment of patients with relapsing forms of multiple sclerosis. Ublituximab is an investigational glycoengineered monoclonal antibody that targets CD20,…
The Food and Drug Administration (FDA) has approved Lyvispah (baclofen) oral granules for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.…
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for fenfluramine, for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS). An amphetamine derivative, fenfluramine was initially…
Sagent Pharmaceuticals, Inc. is voluntarily recalling 4 lots of Levetiracetam Injection, USP 500mg per 5mL, to the user level due to a lack of container closure integrity found in reserve sample vials that may result…
The American Academy of Neurology (AAN) has issued updated guidelines on initiating dopaminergic therapy for motor symptoms in early Parkinson disease. According to the guidelines, counseling should be provided to individuals with early Parkinson disease…
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