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WASHINGTON, D.C. — The U.S. Food and Drug Administration finalized an expedited regulatory pilot that will pair drug companies with qualified research institutions to shorten the path to first-in-human clinical …
FDA Opens Expedited Drug Trial Pilot to Cut Development Delays Read More
PHILADELPHIA, PA & COPENHAGEN, Denmark — Alveus Therapeutics said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for ALV-100, allowing the company to begin clinical …
FDA Clears Alveus Weight-Loss Drug, Launching U.S. Trial After First Dose Read More
MALVERN, PA — MAXONA Pharmaceuticals has taken a key step toward advancing its flagship pain therapy, filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration …
MAXONA Pharmaceuticals Submits FDA Application for Non-Opioid Pain Treatment Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has unveiled the Commissioner’s National Priority Voucher (CNPV) program, aiming to streamline the drug approval process and address critical health …
FDA Introduces Priority Voucher Program to Accelerate Drug Approvals Read More