The study included approximately 400 adults with a history of bipolar I disorder who had a current episode of mania.
Detect, Inc. is voluntarily recalling specific lots of the Detect COVID-19 Test™ due to an increased risk of false negative results.
The bivalent formulations contain the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The designation is supported by data from 3 clinical studies.
The resubmitted NDA was in response to a Complete Response Letter issued by the FDA in December 2021.
If approved, the OTC nasal spray would deliver 4mg of naloxone per spray.
The BLA is supported by data from the phase 3 RENOIR trial which included approximately 37,000 adults 60 years of age and older.
AXS-05 is an investigational agent consisting of a proprietary formulation of dextromethorphan and bupropion.
The trial compared Spravato (esketamine nasal spray) to quetiapine extended-release, both in combination with a continuing SSRI or SNRI.
Serdexmethylphenidate is a proprietary prodrug of d-methylphenidate.
Gantenerumab is an investigational immunoglobulin G1 antibody designed to increase the clearance of soluble amyloid beta from the brain.
Findings showed that the booster dose elicited robust antibody responses comparable to, or exceeding levels associated with the efficacy data in the primary series of the vaccine.
The bivalent Moderna and Pfizer-BioNTech COVID-19 Vaccines are authorized as a single booster dose at least 2 months after the primary or booster vaccination.
The quadrivalent modRNA influenza vaccine candidate uses mRNA technology, which requires only the genetic sequence of the virus.
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.
Approval was based on a prospective study that included 44 participants who underwent C-section delivery.
The extended shelf-life of Paxlovid is authorized for 4 lots that were manufactured with a 9-month expiry prior to the issuance of Emergency Use Authorization.
An individual is considered fully vaccinated about 2 weeks after the second dose of Jynneos and 4 weeks after receiving ACAM2000.
The designation was based on data from 2 phase 2 proof-of-concept studies that evaluated VX-548 for acute pain following abdominoplasty or bunionectomy surgery.
Patients received PH94B or placebo intranasally 20 minutes before an induced public speaking challenge to relieve symptoms of anxiety.
Pharmacodynamic studies have shown that nalmefene has a longer duration of action than naloxone.
