Chester County News and Community Website
WILMINGTON, DE — NRx Pharmaceuticals Inc. (Nasdaq: NRXP) said it received guidance from the U.S. Food and Drug Administration that could allow the company to file a New Drug Application …
NRx Reports FDA Guidance on NRX-100 Approval Path Read More
PHOENIXVILLE, PA — Facet Life Sciences has released the second edition of “FDA and Intellectual Property Strategies for Medical Device Technologies,” an updated guide for medical device developers, the company …
Facet Life Sciences Releases Second Edition of Medical Device Book Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it has received “study may proceed” clearance from the U.S. Food and Drug Administration to initiate a Phase 2b dose-optimization trial …
Medicus Pharma Receives FDA Clearance to Begin Phase 2b Teverelix Study Read More
What This Means for You Food Safety: The FDA has launched a new review of the food preservative BHA to determine whether it remains safe under current uses. Women’s Health: …
FDA Reassesses Food Preservative, Updates Hormone Therapy Warnings, and Approves New Pancreatic Cancer Device Read More
WILMINGTON, DE — AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for DATROWAY® (datopotamab deruxtecan-dlnk) has been accepted and granted Priority Review by the U.S. Food and Drug Administration for …
DATROWAY Gains Priority Review for Aggressive Breast Cancer Read More PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) has received clearance from the U.S. Food and Drug Administration to proceed with a Phase 2b clinical study of Teverelix, a long-acting …
FDA Clears Medicus to Advance Prostate Cancer Drug Aimed at Heart-Risk Patients Read More
WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) said the U.S. Food and Drug Administration has cleared its investigational new drug application for PRT12396, allowing the company to begin a …
FDA Clears Prelude’s Experimental Cancer Drug, Opening New Path for Blood Disorders Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration is rolling out a sweeping set of initiatives aimed at reshaping the nation’s drug and food systems, launching a new pilot …
FDA Unveils Triple Push: Drug Onshoring, Cleaner Food Labels, GLP-1 Crackdown Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has approved a new frontline treatment option for adults newly diagnosed with multiple myeloma who …
FDA Clears Johnson & Johnson Myeloma Combo, Expanding Frontline Care 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