Chester County News and Community Website
In an effort to ensure the safety and well-being of children involved in clinical trials, the U.S. Food and Drug Administration (FDA) recently issued draft guidance that provides the agency’s …
FDA Issues Draft Guidance on Including and Protecting Children in Clinical Trials Read More
WEST CHESTER, PA — Centinel Spine, LLC announced the first implantation recently of its prodisc® C Vivo Cervical Total Disc Replacement (TDR) product. In July, the company received U.S. Food …
Centinel Spine Announces First Commercial Use of prodisc C Vivo Read More
The U.S. Food and Drug Administration recently approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes …
FDA Approves Treatment for Rare Genetic Disease Read More
COLLEGEVILLE, PA — Provepharm, a French company with operations in the United States, announced that it recently received FDA New Drug Approval for the marketing of its injectable BLUDIGO™ (Indigotindisulfonate Sodium) Injection.
Provepharm Announces FDA Approval for BLUDIGOTM Read More
MALVERN, PA — Waypoint Orthopedics, Inc. announced the company’s recent submission of an FDA 510(k) application for the Waypoint GPS™ – a smart bone awl for use during pedicle screw …
Waypoint Orthopedics Submits FDA 510(k) Application for Waypoint GPS Read More
WASHINGTON, D..C. — The U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) on July 06, 2022, to authorize state-licensed pharmacists to prescribe …
FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations Read More
EXTON, PA — Ricoh USA, Inc. recently announced RICOH 3D for Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling.
Ricoh’s Healthcare Solution Receives FDA 510(k) Clearance for Craniomaxillofacial and Orthopedic Anatomic Modeling Read More
WEST CHESTER, PA — Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA) announced that the U.S. Food and Drug Administration (FDA) this week issued a Complete Response Letter (CRL) regarding its New …
Verrica Receives Complete Response Letter from the FDA Read More
WASHINGTON, D.C. — The U.S. Food and Drug Administration says that it recently approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older …
FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder Read More
MALVERN, PA — Galera Therapeutics, Inc. (Nasdaq: GRTX) this week announced its intent to file a New Drug Application (NDA) for avasopasem manganese (avasopasem) for the treatment of radiotherapy-induced severe …
Galera Announces Plan to Submit Avasopasem NDA by Year End Read More