BILLERICA, Mass. — Quanterix Corporation (NASDAQ: QTRX), a leading provider of ultra-sensitive research products and high-definition diagnostics, announced today that its Simoa® phospho-Tau 217 (p-Tau 217) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s...
treatment News
London, UK – Researchers have developed a revolutionary biosensor using terahertz (THz) waves that can detect skin cancer with exceptional sensitivity, potentially paving the way for earlier and easier diagnoses. Published in the IEEE Transactions on Biomedical Engineering, the study presents a significant advancement in early cancer detection, thanks to...
ASHBURN, Va. — Quoin Pharmaceuticals Ltd., a specialty pharmaceutical company focused on rare and orphan diseases, today announced that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its two ongoing clinical trials for QRX003, which is being developed as a...
ASHBURN, Va. — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) , a specialty pharmaceutical company focused on rare and orphan diseases, today announced clearance from the U.S. Food and Drug Administration (FDA) to recruit teen subjects aged 14 years and older into its two ongoing clinical trials for QRX003, which is being...
ASHBURN, Va. — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX), a specialty pharmaceutical company exclusively focused on the development and commercialization of innovative therapies that treat rare and orphan diseases, today announced it has filed U.S. and International patent applications for a novel combination product as a potential treatment of Netherton Syndrome....
NANTONG and SUZHOU, China — Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to RAG-18, one of the company’s lead saRNA product candidates. This designation follows the recent Rare Pediatric Disease...
HOUSTON, Texas & PARIS, France — RadioMedix, Inc. and Orano Med, two clinical stage radiopharmaceutical companies, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to AlphaMedixTM (212Pb-DOTAMTATE) for the treatment of adult patients with unresectable or metastatic, progressive somatostatin receptor expressing...
NEW HAVEN, Conn. — Rallybio Corporation (Nasdaq: RLYB), a clinical-stage biotechnology company committed to identifying and accelerating the development of life-transforming therapies for patients with severe and rare diseases, today announced a collaboration with Johnson & Johnson to support the development of complementary therapeutic approaches aimed at reducing the risk...
NEW HAVEN, Conn. — Rallybio Corporation announced preliminary Phase 1 multiple ascending dose (MAD) data for RLYB116, an innovative, long-acting, low volume subcutaneously injected inhibitor of complement component 5 (C5), in development for patients with complement-mediated diseases. The Phase 1 MAD study for RLYB116 evaluated the safety, tolerability, pharmacokinetics (PK),...
NOVATO, California — The Phase 2b clinical trial will enroll up to six cystinosis patientswith a history of good compliance using the currently availableimmediate-release form of cysteamine bitartrate, the only drug cleared formarketing by the U.S. Food and Drug Administration (“FDA”) and EuropeanMedicines Agency (“EMEA”) to treat cystinosis. The clinical...