Chester County News and Community Website
PHILADELPHIA, PA — Instanosis Inc. announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Xylazine Rapid Test (Urine), a diagnostic device designed to detect …
FDA Grants Breakthrough Status to Instanosis Xylazine Test Read More
PLYMOUTH MEETING, PA — Harmony Biosciences (Nasdaq: HRMY) said the U.S. Food and Drug Administration has approved a supplemental new drug application for WAKIX (pitolisant) tablets to treat cataplexy in …
FDA Approves Harmony’s WAKIX for Pediatric Cataplexy Read More
WASHINGTON, D.C. — The Food and Drug Administration has released draft guidance outlining a new pathway to approve highly individualized treatments for ultra-rare diseases and has granted expedited approval to …
FDA Unveils Ultra-Rare Therapy Path, Fast-Tracks Lung Drug Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved a new monthly dosing schedule for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), to …
Johnson & Johnson Receives FDA Approval for Monthly RYBREVANT FASPRO Dosing Read More
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