NVX-CoV2373 is engineered from the genetic sequence of SARS-CoV-2 using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein.
Researchers used data from the State Unintentional Drug Overdose Reporting System in order to assess trends in gabapentin-involved overdose deaths.
The placebo-controlled ORCA-2 study evaluated the safety and efficacy of cytisinicline as a treatment for smoking cessation in 810 adult smokers.
The Agency is currently seeking public comment on this potential modification to the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy.
The CRL states that the application cannot be approved in its current form.
The Emergency Use Authorization was based on safety and immunogenicity data provided to the Agency.
Acadia Pharmaceuticals resubmitted the sNDA after addressing issues raised in a Complete Response Letter issued by the Agency.
The road for Avenue Therapeutics’ regulatory submission for tramadol IV has been a bumpy one.
The randomized, double-blind, placebo controlled, fully remote study was led by The Feinstein Institutes for Medical Research at Northwell Health and Cold Spring Harbor Laboratory.
Molnupiravir is an orally administered form of a ribonucleoside analogue that inhibits the replication of SARS-CoV-2.
