Diana Ernst, RPh

The FDA clearance was based on data from a clinical study that included 221 adults diagnosed with ADHD.

The generic product is being made available by Cranbury Pharmaceuticals.

Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis.

The investigational product is an extended-release tablet formulation of diazoxide chloride, the crystalline salt of diazoxide.

All of the affected individuals were females who received the injections in non-health care settings by untrained individuals who purchased the product from unlicensed sources.

The double-blind, phase 3 study included 2 groups of patients, those who were not on positive airway pressure therapy and those who were.

A regulatory decision is expected on February 14, 2025.

The drug/device combination therapy provides a continuous subcutaneous infusion of apomorphine through an infusion pump.

The use of whole blood at the point of care eliminates the need for plasma extraction.

The open-label, external placebo-controlled trial evaluated the efficacy and safety of Ultomiris in 58 adults with anti-AQP4 antibody positive NMOSD.

The approval was based on data from 37 pediatric patients with MLD treated with Lenmeldy who were enrolled in 2 open-label clinical trials or treated under expanded access frameworks.

The decision to discontinue Aduhelm was not related to any safety or efficacy concerns.

Several changes were made to the adult immunization schedule for 2024.

Researchers assessed vaccine provider behaviors and attitudes regarding pneumococcal vaccine recommendations and knowledge of the recommendations.

The FDA has issued a Complete Response Letter to AstraZeneca regarding the sBLA for ravulizumab-cwvz for neuromyelitis optica spectrum disorder.

The Food and Drug Administration has approved Tyruko (natalizumab-sztn), a biosimilar to Tysabri (natalizumab).

Top-line results were announced from a phase 3 study evaluating fasedienol (PH94B) nasal spray in adults diagnosed with social anxiety disorder.

A blood-based biomarker test that assesses beta amyloid protein has been made available by Quest Diagnostics to help individuals identify their risk of developing Alzheimer disease.

Daxxify is supplied as a lyophilized powder for reconstitution in single-dose 50 Unit and 100 Unit vials.

Ulotaront is a trace amine-associated receptor 1 agonist with 5-HT1A agonist activity.

In a joint letter, the FDA and DEA provide an update on the steps being taken to resolve the shortages.

The prescribing information for Vigadrone includes a Boxed Warning regarding the risk of permanent vision loss.

Each RiVive nasal spray unit contains 3mg of naloxone HCl and delivers a single dose.

Treatment with donanemab significantly slowed cognitive and functional decline in early Alzheimer disease.

The FDA has issued a warning regarding the use of certain ultrasound devices that have been unlawfully sold to consumers for medical purposes.

The FDA has expanded the approval of Liletta (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding.

The FDA has issued a Complete Response Letter to Amneal regarding the NDA for IPX203 for the treatment of Parkinson disease.

Moderna has initiated a rolling submission of a BLA for mRNA-1345, an investigational RSV vaccine for prevention of RSV disease in adults aged 60 years or older.

The FDA has granted Fast Track designation to ACI-24.060, an anti-amyloid beta active immunotherapy candidate for the treatment of Alzheimer disease.

The FDA has granted traditional approval to Leqembi for the treatment of Alzheimer disease based on the benefit established in a trial.