The BLA is supported by data from the phase 3 MycarinG study.
All articles by Brian Park, PharmD
The approval was based on data from the phase 3 ULTIMATE 1 and ULTIMATE 2 trials that compared ublituximab-xiiy to teriflunomide in patients with relapsing multiple sclerosis.
The BLA is supported by data from a clinical trial which included 2341 healthy individuals 10 through 25 years of age.
Omburtamab is an investigational radiolabeled monoclonal antibody designed to target tumor cells that express B7-H3.
The bivalent formulations contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
In preclinical studies, WP1122 has shown to increase cellular uptake of 2-DG, increase drug half-life, and increase the ability to cross the blood brain barrier.
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
SRP-9001 is an investigational gene transfer therapy designed to deliver a shortened, functional component of dystrophin to muscle tissue.
The approval was based on data from an expanded access program which evaluated the safety of amifampridine in 21 pediatric patients for at least 1 year.
The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study.
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis.
Optic neuritis is a rare autoimmune disease characterized by the inflammation of the optic nerve.
The submission is supported by data from the phase 3 PREVENT-19 trial and the phase 2 COV-BOOST trial.
Under the EUA, Jynneos can be administered either intradermally for individuals aged ≥18 years or subcutaneously for individuals aged <18 years.
The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY and phase 2 Study-019 trials.
The approval was based upon a bioavailability study in healthy adults comparing baclofen oral tablets to Lyvispah.
SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump.
Elezanumab is a monoclonal antibody of the human IgG1 isotype that works by binding selectively to repulsive guidance molecule A.
The FDA has approved MenQuadfiTM Meningococcal (Groups A, C, Y, W; Sanofi Pasteur) Conjugate Vaccine for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in patients aged ≥2 years.