Health news
Topline results were announced from a phase 3 trial evaluating the efficacy and safety of nabiximols oromucosal spray (JZP378) on clinical measures of spasticity in adults with multiple sclerosis. Nabiximols oromucosal spray is an investigational…
Topline results were announced from a phase 3 study evaluating eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Hereditary ATTR is a severe, progressive and life-threatening disease caused by the abnormal formation and aggregations…
The Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee voted 3 “yes” and 9 “no” on whether the available evidence supports the conclusion that pimavanserin is effective for the treatment of hallucinations and delusions…
A phase 2 trial evaluating the efficacy and safety of crenezumab in adults with autosomal dominant Alzheimer disease (ADAD) did not meet its coprimary endpoints, according to Genentech. ADAD is a rare, inherited form of…
Radicava ORS® (edaravone oral suspension) is now available for the treatment of adults with amyotrophic lateral sclerosis (ALS). Radicava ORS contains the same active ingredient as Radicava, which was originally approved in 2017 as an…
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vutrisiran for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Polyneuropathy of hATTR is caused by the…
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for AMX0035 (sodium phenylbutyrate and taurursodiol) for the treatment of amyotrophic lateral sclerosis (ALS). The new Prescription Drug…
Amneal has announced the launch of 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 gamma-aminobutyric…
The Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for ublituximab for the treatment of patients with relapsing forms of multiple sclerosis (RMS). The new Prescription Drug…
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for omaveloxolone for the treatment of Friedreich ataxia. Friedreich ataxia is a rare genetic disease caused by mutations in…
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