Fenfluramine Gets Priority Review for Lennox-Gastaut Syndrome
The sNDA submission is supported by data from a phase 3 trial that compared the efficacy and safety of fenfluramine with placebo in 263 patients aged 2 to 35 years with LGS.
Article Type: Distributed Content
CDC Issues Alert on Omicron Variant, Provides HCP Recommendations
The CDC is recommending that health care providers take a travel history for all suspected and confirmed cases of COVID-19.
Pneumococcal 15-Valent Conjugate Vaccine Gets Priority Review for Pediatric Use
The application is supported by data from phase 2 and phase 3 clinical studies that assessed the efficacy and safety of Vaxneuvance in infants, children, and adolescents.
Negative Allosteric Modulator Gets Fast Track Status for Social Anxiety Disorder
The Company will evaluate BNC210 in patients with SAD in the phase 2 PREVAIL trial.
Lack of Confirmatory Trials Leads to Withdrawal of Multiple Myeloma Treatment
Continued approval required further verification and description of clinical benefit in confirmatory trials.
FDA Panel Votes in Favor of COVID-19 Pill But With Concerns
Molnupiravir is an orally administered form of a ribonucleoside analogue that inhibits the replication of SARS-CoV-2.
November 2021: 5 Notable Drug Approvals
The new approvals include Besremi, Fyarro, Livtencity, Voxzogo, and Vuity.
Clinicians Forced to Re-Evaluate Office Practices
Developing an effective case management approach should be a key component of any effort to adapt to the changing patient care environment.
Cyclophilin Inhibitor Fast Tracked for Nonalcoholic Steatohepatitis
In preclinical studies, CRV431 has been shown to reduce liver fibrosis and hepatocellular tumor burden.
FDA Rejects Pedmark NDA Again Citing Manufacturing Deficiencies
The application could not be approved in its present form due to manufacturing deficiencies.
