Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis.
All articles by Brian Park, PharmD
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.