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WASHINGTON, D.C. — The Department of Health and Human Services is backing a new clinical-trial model that would use predictive simulations, real-time statistical analysis and automation to reduce the time, …
HHS Targets Clinical Trial Costs With Adaptive Trial Push Read More
PLYMOUTH MEETING, PA — Adverse-event reports for Braeburn’s Brixadi remained low and relatively stable during its first 18 months on the U.S. market, according to a company-funded study examining federal …
Braeburn Study Finds Low Adverse-Event Reporting for Brixadi Read More
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
WAYNE, PA — Teleflex Incorporated (NYSE: TFX) is using clinical data from an investigator-led study to support trans-radial use of its Dynetic-35 stent for treating iliac artery lesions, offering physicians …
Teleflex Study Backs Radial Access for Iliac Stenting Read More
WAYNE, PA — CluePoints made three clinical data review applications generally available ahead of the SCDM 2026 conference Sept. 14-17 in Raleigh, North Carolina, extending its software beyond risk-based quality …
CluePoints Expands Clinical Data Tools With AI Review Read More
WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) Chief Scientific Officer Jeffrey Martini will address evidence gaps and regulatory barriers affecting drug repurposing at an Aug. 5 FDA public workshop …
Palvella Executive to Address FDA Drug Repurposing Barriers Read More
WASHINGTON, D.C. — The Food and Drug Administration selected Dexcom Inc. as the first participant in a federal pilot linking digital health-device oversight with a Medicare payment model that rewards …
FDA Selects Dexcom for Medicare Digital Health Pilot Read More
HORSHAM, PA — STRATA Skin Sciences, Inc. highlighted new clinical data showing its XTRAC excimer laser significantly improved repigmentation outcomes in children with progressive vitiligo when paired with oral JAK …
STRATA Study Signals Expanded Market for Vitiligo Therapy Read More
WASHINGTON, D.C. — Federal regulators have cleared the way for certain pancreatic cancer patients to access an experimental drug earlier than usual, approving a rapid pathway that allows treatment outside …
FDA Fast-Tracks Access to Experimental Pancreatic Drug Read More
WASHINGTON, D.C. — Federal regulators are moving to speed up drug development by launching real-time clinical trials that allow safety data and results to be reviewed as studies are underway …
FDA Pushes Faster Drug Approvals With Real-Time Trials Read More