Chester County News and Community Website
WASHINGTON, D.C. — The U.S. Food and Drug Administration announced two major actions last week: making its internal drug application checklists public to improve transparency and issuing the first-ever emergency …
FDA Publishes Drug Filing Checklists, Issues First-Ever Emergency Use for Animal Drug Read More
WEST CHESTER, PA — Centinel Spine®, LLC has received U.S. Food and Drug Administration (FDA) Premarket Approval for two-level indications of its prodiscC Vivo and prodiscC SK cervical total disc …
Centinel Spine Secures FDA Approval for Two-Level Use of prodiscC Vivo and prodiscC SK Devices Read More
WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced it has received the second year of funding under its U.S. Food and Drug Administration (FDA) Office of Orphan Products Development …
Palvella Therapeutics Receives Second Year of FDA Grant Funding for Phase 3 SELVA Trial Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration has awarded nine companies priority review vouchers under its new Commissioner’s National Priority Voucher (CNPV) pilot program, designed to accelerate approval …
FDA Names Nine Recipients in New Fast-Track Program for High-Priority Drugs Read More
HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved TREMFYA® (guselkumab) for children six years and older weighing at least 40 …
FDA Approves Johnson & Johnson’s TREMFYA for Pediatric Psoriasis and Psoriatic Arthritis Read More
WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) has re-filed its Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for KETAFREE™, a preservative-free intravenous ketamine …
NRx Re-Files FDA Application for Preservative-Free IV Ketamine Read More WASHINGTON, D.C. — The U.S. Food and Drug Administration has conditionally approved the first treatment in the nation to prevent and combat New World screwworm infestations in cattle — a …
FDA Greenlights First Drug to Combat Deadly Screwworm Threat in U.S. Cattle Read More
WILMINGTON, DE — AstraZeneca and Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to their supplemental Biologics License Application (sBLA) for …
FDA Grants Priority Review for ENHERTU Combo in Advanced Breast Cancer Read More
NEWTOWN, PA — Helius Medical Technologies, Inc. (NASDAQ: HSDT) has filed a 510(k) submission with the U.S. Food and Drug Administration seeking to expand the label of its Portable Neuromodulation …
Helius Files FDA Submission for PoNS Stroke Therapy Label Expansion Read More WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced it has received U.S. Food and Drug Administration (FDA) approval of a Suitability Petition allowing the company to proceed with its …
NRx Wins FDA Nod to Advance Preservative-Free Ketamine Product KETAFREE Read More