STAT8d
U.S. taxpayers should stop funding clinical trials of industry-owned drugs
I worked closely with NCI’s Investigational Drug Branch (IDB) from 1990-2016, including as a principal investigator of one of ...
Boston.com on MSN12d
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 ...
clinicalpainadvisor.com5d
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for ...
BioPharma Dive13d
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 ...
JD Supra13d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
often by the time of approval, with clearly defined milestones to ensure completion.[16] Trials should efficiently verify clinical benefits and align with the drug’s intended use. Delays or lack ...
The American Journal of Managed Care12d
Suzetrigine: First-in-Class Nonopioid Pain Therapy Is Approved by FDA
Suzetrigine (Journavx) is the first new drug approved to treat acute pain in over 20 years and the first to be classified as ...