The applications are based on data from the phase 3 PHALCON-HP trial.
The recalled lot of Lidocaine HCl Topical Solution 4% (40mg/mL) was distributed at the wholesale and retail distribution levels.
BMN 307 is an investigational AAV5-phenylalanine hydroxylase gene therapy designed to normalize phenylalanine concentration levels.
The Food and Drug Administration has accepted for review the supplemental New Drug Application for viloxazine extended-release for the treatment of attention-deficit hyperactivity disorder in adults. The application is supported by data from a multicenter, randomized, double-blind, placebo-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT04016779), which assessed the efficacy and safety of viloxazine in 374 adults…
The sNDA and NDA are supported by data from the open-label phase 2a HOPE-KIDS1 study.
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.
VS-01 is a novel liposomal-based intraperitoneal fluid that acts as a clearance enhancer of toxic metabolites, in particular ammonia, from the body.
Multrys is supplied in 1mL single-dose vials containing zinc 1000mcg, copper 60mcg, manganese 3mcg, and selenium 6mcg.
Krabbe disease is a rare inherited disorder caused by mutations in the GALC gene.