Chester County News and Community Website
WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) recently received a Discipline Review Letter from the U.S. Food and Drug Administration identifying only minor administrative changes for its ketamine application …
NRx Reports FDA Feedback, Progress on Ketamine Application Read More
WASHINGTON, D.C. — Federal health officials are moving to speed the development of psychedelic-based treatments for serious mental illness, following a new executive order aimed at expanding access to emerging …
FDA Moves to Fast-Track Psychedelic Mental Health Treatments Read More
WASHINGTON, D.C. — Medicare patients could gain access to certain breakthrough medical devices months sooner under a new federal initiative designed to speed up approval and coverage decisions.
Medicare Patients Could Get New Devices Faster Under Plan Read More
LANGHORNE, PA — The U.S. Food and Drug Administration has extended the review period for Savara Inc.’s (Nasdaq: SVRA) biologics license application for molgramostim by three months, setting a new …
FDA Extends Review of Savara’s Molgramostim Application to November Read More
WILMINGTON, DE — The U.S. Food and Drug Administration recently approved RAPIBLYK® (landiolol) for pediatric patients from birth to under 18 years old with supraventricular tachycardia, expanding its use beyond …
FDA Approves Rapiblyk for Pediatric SVT Patients in U.S. Read More
WASHINGTON, D.C. — Federal regulators say efforts to reduce animal testing in drug development are advancing, with the Food and Drug Administration reporting early progress on a plan aimed at …
FDA Push to Cut Animal Testing Shows Early Progress Read More
PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it submitted an Orphan Drug Designation application to the U.S. Food and Drug Administration for SkinJect (D-MNA) to treat basal cell …
Medicus Pharma Submits Orphan Drug Application for SkinJect Read More
WASHINGTON, D.C. — President Donald J. Trump has signed an executive order directing federal agencies to accelerate research, regulatory review, and potential patient access for experimental psychedelic drugs aimed at …
Trump Order Expands Federal Push on Psychedelic Therapies Read More
WARMINSTER, PA — Arbutus Biopharma Corporation (Nasdaq: ABUS) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its drug candidate imdusiran for the treatment of …
Arbutus Drug Candidate Receives FDA Fast Track Designation Read More
WASHINGTON, D.C. — Federal regulators are exploring whether testosterone replacement therapy could be expanded to treat low libido in certain men, a move that could broaden access to treatment for …
FDA Signals Potential Expansion of Testosterone Therapy Use Read More