Brian Park, PharmD

The NDA is supported by data from a phase 1/2 trial that compared the investigational aripiprazole 2-month, long-acting injectable to aripiprazole 1-month depot.

The SAINT Neuromodulation System is an integrated hardware, software, and cloud-computing system that uses structural and functional MRI.

In general, routine annual vaccination is recommended for all patients 6 months of age and older who have no contraindications and should be completed by the end of October.

The FDA has authorized the bivalent Moderna and Pfizer-BioNTech COVID-19 Vaccines as a single booster dose at least 2 months following the primary or booster vaccination.

The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October.

The submission is supported by data from the phase 3 PREVENT-19 trial and the phase 2 COV-BOOST trial.

Auvelity is supplied as dextromethorphan HBr 45 mg/bupropion HCl 105 mg extended-release tablets in 30-count bottles.

The phase 3 EMERGENT-2 trial included 252 patients with schizophrenia who were experiencing symptoms of psychosis.

Under the EUA, Jynneos can be administered either intradermally for individuals aged ≥18 years or subcutaneously for individuals aged <18 years.

The sNDA for Alzheimer disease psychosis included data from the phase 3 HARMONY and phase 2 Study-019 trials.