LANCASTER, Pa. — On October 27, 2023, the third International Limb Girdle Muscular Dystrophy (LGMD) Conference will be hosted by The Speak Foundation at the Grand Hyatt Washington, DC. The inaugural International LGMD conference was held in Chicago in 2019 and over 400 patients, caregivers, physicians, researchers and advocacy groups...
treatment News
Wellington, New Zealand – The Malaghan Institute of Medical Research in collaboration with Wellington Zhaotai Therapies Limited today announced results of its phase 1 dose escalation trial of a new third generation anti-CD19 chimeric antigen receptor (CAR) T-cell therapy was presented at the American Society of Hematology (ASH) Annual Meeting...
By Raffaele Pereno STOCKHOLM, Sweden – Reporting at BioEurope 2024, CheckOrphan had the opportunity to meet a promising biotech company, whose lead product seeks to stop the progression of amyotrophic lateral sclerosis (ALS) in its tracks. Tikomed AB is a privately owned pharmaceutical company based in Viken, Sweden. Adam Bruce,...
COPENHAGEN, Denmark — Genmab A/S (Nasdaq: GMAB) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic...
NEW YORK, NY — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has submitted an FDA request to obtain Orphan Drug Designation for intranasal foralumab for the treatment of non-active secondary progressive Multiple Sclerosis (na-SPMS). This...
ST. LOUIS, MO – Each year, tuberculosis (TB) kills more people than any other infectious disease, falling out of the top spot only temporarily during the COVID-19 pandemic. Despite TB’s wide reach and some lost progress during the COVID-19 pandemic, researchers believe it is possible to eradicate TB through advances...
San Diego, Calif. – The BIO Convention always highlights new regulatory developments, cutting edge technologies and the best new companies that are going change the face of healthcare in the near future, and 2024’s conference did not disappoint. The first of a series of CheckOrphan articles highlighting companies changing the...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, Tonmya™, for the company’s drug product candidate TNX-102 SL for the management of fibromyalgia. Tonmya...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly...
CHATHAM, N.J. — Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900 (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-enhanced formulation...