What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of opioids.
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Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
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FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
F.D.A. Approves Drug to Treat Pain Without Opioid Effects
The drug, Journavx by Vertex Pharmaceuticals, blocks pain signals to the brain, making it nonaddictive. The Food and Drug ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
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Vertex’s non-opioid pain drug gets FDA approval in milestone for company and research
Despite high demand for an option like Journavx, doctors fear the drug’s price could be a hangup for insurers and limit ...
FDA approves new type of nonopioid painkiller for acute pain
The drug, Journavx, from Vertex Pharmaceuticals, reduced pain after surgery in clinical trials. Experts hope it can lead to fewer opioid prescriptions.