Health care professionals should be aware of these risks and select patients for treatment accordingly.
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The Agency could not approve the BLA due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.
Valbenazine 40mg achieved greater placebo-adjusted improvement in chorea as early as week 2 and sustained greater efficacy through week 12 compared with placebo.
The application is supported by data from two phase 3 trials: an induction study, INSPIRE and a maintenance study, COMMAND.
Rezzayo is supplied as a solid (cake or powder) in a single-dose vial containing 200mg of rezafungin.
The SC formulation of efgartigimod alfa plus hyaluronidase-qvfc is currently marketed under the brand name Vyvgart Hytrulo for generalized myasthenia gravis.
Lantidra is an allogeneic pancreatic islet cellular therapy.
Atorvaliq oral suspension is supplied in a 150mL bottle containing 20mg/5mL of atorvastatin calcium.
Elevidys is supplied as a customized kit to meet dosing requirements for each patient.
The phase 3 INVIGORATE-2 trial included 131 allergic conjunctivitis patients 18 years of age and older.