OPNT003 is an intranasal formulation containing the high affinity opioid antagonist, nalmefene.
The approval was based on data from adequate and well-controlled studies with risperidone long-acting injection (intramuscular).
Nirsevimab is a long-acting anti-RSV for nirsevimab for the prevention of RSV lower.
The MAPP2 study included 104 patients who received either MDMA or placebo plus psychotherapy.
BresoDX1 is designed to record a patient’s physiological signals during sleep using a sensor and a pulse oximeter.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
RiVive is an opioid antagonist that reverses the effects of opioids, including respiratory depression, sedation, and hypotension.
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.
