Prefilled Syringe Formulation of Neostigmine Methylsulfate Now Available
The single-dose prefilled syringe is supplied in a 3mg/3mL dosage strength and is the first manufacturer-prepared formulation of this product on the market.
All articles by Steve Duffy
FDA to Review Ozanimod for Relapsing Forms of MS
The FDA has accepted for review the New Drug Application (NDA) for ozanimod (Celgene), an investigational treatment for relapsing forms of multiple sclerosis (MS).
FDA Grants Orphan Drug Status to Investigational Treatment for Spinocerebellar Ataxia
The FDA has granted Orphan Drug designation to CAD-1883 (Cadent Therapeutics), an investigational treatment for spinocerebellar ataxia (SCA).
FDA Clears Smartphone-Controlled Electroceutical for Acute Treatment of Migraine
The Food and Drug Administration (FDA) has cleared Nerivio Migra (Theranica), a prescription smartphone-controlled device for the acute treatment of migraine with or without aura in adults who do not have chronic migraine.
Phase 3 Study of Investigative Glioblastoma Treatment Halted
AbbVie has halted enrollment in all ongoing studies of depatuxizumab mafodotin, after an Independent Data Monitoring Committee (IDMC) recommended a phase 3 study of the treatment be stopped due to a lack of survival benefit.
CVS Pharmacy Introduces Third Party Testing for All Dietary Supplements
Vitamins and supplements sold at CVS Pharmacy will now go through third party testing to verify the accuracy of the dietary ingredients listed on the packaging and to confirm that the product is free of certain additives.
CBD Gel Gets Fast Tracked for Behavioral Symptoms Associated With Fragile X Syndrome
The FDA has granted Fast Track designation to Zygel (ZYN002; Zynerba), a cannabidiol gel for the treatment of behavioral symptoms associated with Fragile X syndrome (FXS).
FDA Grants Fast Track Status to Microbiota Transfer Therapy for Autism
The FDA has granted Fast Track status to the microbiota transfer therapy, Full-Spectrum Microbiota (FSM), for the treatment of children with autism spectrum disorder.
Breakthrough Therapy Status Granted to Inebilizumab for Neuromyelitis Optica Spectrum Disorder
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to inebilizumab (Viela Bio), an investigational monotherapy for neuromyelitis optica spectrum disorder (NMOSD).
Orphan Drug Designation Granted to Pamrevlumab for Duchenne Muscular Dystrophy
The Food and Drug Administration (FDA) has granted Orphan Drug designation to pamrevlumab (FibroGen), for the treatment of patients with Duchenne muscular dystrophy (DMD).
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