Gimoti, a dopamine-2 (D2) antagonist, is a nasal spray formulation of metoclopramide.
FB-401 is a topically applied live biotherapeutic that consists of 3 therapeutic strains of commensal Roseomonas mucosa.
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
The trial is investigating the efficacy, safety, and immunogenicity of mRNA-1273 at the 100mcg dose.
The applications are supported by data from the CheckMate -9ER trial that compared nivolumab, a programmed death receptor-1 blocking antibody, plus cabozantinib, a tyrosine kinase inhibitor, to sunitinib.
The update was based on data from the phase 3 PSO-LONG trial, a randomized, double-blind, vehicle-controlled study that evaluated the long-term use of Enstilar Foam in 545 adults.
The randomized, open-label, controlled trial (Study 31/A5349) had more than 2500 participants ages 12 years and older and included 214 people with HIV.
Qtrypta delivers zolmitriptan, a selective 5-HT1B/1D receptor agonist, using the Company’s proprietary Adhesive Dermally-Applied Microarray (ADAM) technology that consists of a drug-coated microneedle patch.
Results from PNEU-PATH demonstrated comparable immune responses following vaccination with Pneumovax 23 in both treatment groups for the 15 serotypes in V114.
The sNDA is supported by data from the phase 3 ADAURA trial that assessed osimertinib vs placebo in 682 patients with early-stage EGFRm NSCLC after complete tumor resection with or without adjuvant chemotherapy.
