Gantenerumab Designated Breakthrough Therapy for Alzheimer Disease
The FDA has granted Breakthrough Therapy designation to gantenerumab, an anti-amyloid beta antibody, for the treatment of Alzheimer disease.
All articles by Brian Park, PharmD
Ublituximab BLA Submitted for Relapsing Forms of Multiple Sclerosis
Ublituximab is an investigational glycoengineered anti-CD20 monoclonal antibody.
Qulipta Approved for Preventive Treatment of Episodic Migraine
Results from ADVANCE showed statistically significantly greater decreases in mean monthly migraine days with atogepant compared with placebo.
Eisai Begins Rolling BLA Submission of Lecanemab for Early Alzheimer Disease
Lecanemab is an investigational anti-amyloid beta protofibril antibody.
FDA to Review Relugolix Combination Therapy for Endometriosis Pain
The application is supported by data from the phase 3 SPIRIT program, which includes the SPIRIT 1 and SPIRIT 2 studies, as well as an open-label extension study.
Viloxazine Under Review for ADHD Treatment in Adults
The FDA has accepted for review the sNDA for viloxazine extended-release (Qelbree) for the treatment of ADHD in adults.
Invega Hafyera Approved for Twice-Yearly Treatment of Schizophrenia
Results showed that at the end of the 12-month period, treatment with Invega Hafyera was found to be noninferior to Invega Trinza with regard to the primary endpoint.
Trudhesa Nasal Spray Approved for Acute Treatment of Migraine
The approval is supported by data from the phase 3 STOP 301 study, which evaluated the safety and tolerability of Trudhesa in 354 adults with migraine.
FDA to Review sNDA for Purified Cortrophin Gel for Multiple Indications
Purified Cortrophin Gel is a purified adrenocorticotropic hormone.
Vagus Nerve Stimulation System Approved for Post Stroke Rehabilitation Therapy
The Vivistim System features an implantable pulse generator, which is placed just under the skin in the chest of the patient, and a lead wire.
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