Diana Ernst, RPh

Both Companies provided data demonstrating waning neutralizing antibody titers approximately 6 months after completion of the primary series.

The UK study aimed to investigate SARS-CoV-2 transmission and viral load in vaccinated and unvaccinated people with mild Delta variant infection.

The analysis included 49,357 patients undergoing LAAO procedures with the Watchman Left Atrial Appendage Closure device.

Anecdotal reports suggest that naltrexone, an opioid antagonist, may alleviate symptoms associated with CRPS.

Patients treated with the investigational subcutaneous risperidone injection experienced a statistically significant delay in the time to relapse.

The Centers for Disease Control and Prevention continues to recommend COVID-19 vaccination for all individuals 12 years of age and older.

The outpatient procedure provides noninvasive magnetic stimulation through a cushioned helmet to targeted areas of the brain.

The TeenCOVE study (ClinicalTrials.gov: NCT04649151) included over 3700 US adolescents aged 12 to less than 18 years.

Rimegepant is an oral calcitonin gene-related peptide receptor antagonist.

The safety of the vaccine in this patient population was based on data from 2260 adolescent participants.

Currently, the FDA-approved route of administration of Tysabri for MS is through intravenous infusion.

Hizentra is indicated for the treatment of adult patients with CIDP as maintenance therapy to prevent relapse of neuromuscular disability and impairment.

Based on the available information, the panel was unable to decide on next steps for the Janssen COVID-19 vaccine.

Telmisartan, an angiotensin II receptor blocker, is indicated for the treatment of hypertension.

Atogepant is an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist.

In Part 2 of the trial, patients 2-25 years of age received either risdiplam for 24 months or placebo for 12 months followed by risdiplam for 12 months.

The phase 2/3 KidCOVE study [ClinicalTrials.gov: NCT04796896] is evaluating the safety and effectiveness of the vaccine in healthy children between 6 months and less than 12 years of age.

Fully vaccinated individuals can visit with other fully vaccinated people, or unvaccinated people from a single household who are at low risk for severe COVID-19 disease, indoors without wearing masks or physical distancing.

The approval was based on data from a study that compared 2 different maintenance dosages of Panzyga in 142 adults with CIDP.

The approval for IM use was based on data from an open-label, crossover study that assessed the bioequivalence of single doses of 125mcg of Plegridy administered as an SC and IM injection.

The study was conducted by Pfizer and the University of Texas Medical Branch.

The counterfeit products were procured from unauthorized distributors.

The allocation and distribution of vaccine is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services.

This is the first time the Agency has authorized a COVID-19 diagnostic test that provides rapid results at home.

The FDA also approved Vimpat Injection for use in pediatric patients 4 years of age and older.

The investigational treatment, which is administered as a monthly intravenous infusion, binds to aggregated β-amyloid and promotes removal of amyloid from the brain.

The trial will continue as planned and final analysis is expected when the number of confirmed COVID-19 cases reaches 164.

ALKS 3831 is composed of samidorphan, a mu-opioid receptor antagonist, which is co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.

Apomorphine is believed to treat off episodes associated with PD through stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain.

The FDA has approved Enspryng (satralizumab-mwge; Genentech) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.