The INTEGUMENT-PED trial included 652 children 2 to 5 years of age with mild to moderate atopic dermatitis who had a mean BSA of 22% and a range from 3% to 82%.
All articles by Brian Park, PharmD
Xacduro is available as a kit containing a single dose vial of sulbactam 1g and 2 single-dose vials of durlobactam (0.5g in each vial).
Use of the affected product can potentially lead to underdosing or overdosing due to non-uniform distribution of cyclosporine.
The bivalent Pfizer-BioNTech and Moderna COVID-19 vaccines are no longer authorized for use in the United States.
The BA.2.86 variant has multiple genetic differences from previous versions of SARS-CoV-2.
High level of immunity were observed at both 2 weeks and 6 months after a single vaccine.
Ceftobiprole medocaril is a cephalosporin antibiotic for IV administration.
Breyna is available in 160mcg/4.5mcg and 80mcg/4.5mcg dosage strengths.
V116 is an investigational 21-valent pneumococcal conjugate vaccine.
The application is supported by data from the phase 3 InPedILD trial.
The safety, tolerability, and immunogenicity of STAR-0215 is being evaluated in the ALPHA-STAR clinical trial.
Naloxone hydrochloride nasal spray is indicated for the emergency treatment of known or suspected opioid overdose.
Beyfortus is expected to be available for the upcoming 2023-2024 RSV season.
No dosage adjustments are required in patients with any degree of renal impairment.
Removing the prescription requirement improves access to an effective contraceptive method for women of all ages.
No new safety signals were observed in this patient population.
Lantidra is an allogeneic pancreatic islet cellular therapy.
The Company has decided to end the ZEPHYRUS-1 study based on these findings, along with the ZEPHYRUS-2 study.
The approval of empagliflozin for pediatric T2DM was based on data from the phase 3 DINAMO trial.
Gohibic is supplied as a 200mg/20mL solution in a single-dose vial for IV infusion after dilution.
Arexvy is expected to be available for the 2023-2024 RSV season.
BabySat is expected to be available by prescription later this year.
Neffy is an intranasal formulation of epinephrine.
CAL02 is a first-in-class non-biological, broad-spectrum, bacterial virulence neutralizer.
If approved by the third quarter of 2023, the Company expects to make nirsevimab available for the 2023 to 2024 RSV season.
A regulatory decision is expected on November 27, 2023.
The FDA has expanded the approval of Breo Ellipta to include maintenance treatment of asthma in children 5 to 17 years of age.
A PDUFA target date of December 16, 2023 has been set for the application.