Orthofix Medical Inc. a leading global medical technology company, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and the European CE Mark for the TrueLok™ Elevate Transverse Bone Transport (TBT) System.
PHC Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura; hereafter referred to as "PHC"), a subsidiary of PHC Holdings Corporation (Headquarters: Chiyoda-ku, Tokyo; President: Kyoko Deguchi), and Cyfuse Biomedical K.K. announce the successful development of a new production technology(*1) for the commercialization of the field of regenerative and cell therapy. This achievement is the result of a strategic collaboration(*2) and joint research between the two companies.
Kincell Bio, a leader in cell therapy development and manufacturing, is excited to announce the appointment of Larry Pitcher as Chief Operating Officer (COO). Larry brings extensive experience in the advanced therapies Contract Development and Manufacturing Organization (CDMO) space, having had P&L responsibility, deep operational experience including facility expansions and key leadership roles.
Shed, a telehealth clinic specializing in weight loss, is excited to announce Low-Dose Naltrexone (LDN), an innovative, therapeutic solution for individuals managing chronic pain, autoimmune diseases, and metabolic health challenges. LDN works by naturally balancing the immune system, reducing inflammation, and providing pain relief, offering a much-needed alternative for patients seeking to address the root causes of their conditions.
QOL Medical, LLC, a ground-breaking rare disease pharmaceutical company, has announced Sucraid® (sacrosidase) Oral Solution has been shown to be 81% effective in treating patients with Congenital Sucrase-Isomaltase Deficiency (CSID) when used appropriately.1 Eligible patients can now try Sucraid® for free with a 4-day trial offer through their medical provider.
Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) granted approval of MIUDELLA® (copper intrauterine system) for the prevention of pregnancy in females of reproductive potential for up to three years. MIUDELLA is a next-generation, hormone-free, low-dose copper intrauterine device or IUD, the first to be approved by the FDA in the United States in over 40 years.
Avanzanite Bioscience B.V., a pioneering commercial-stage specialty pharmaceutical company advancing life-changing medicines for rare disease patients across Europe, announces the appointment of Abdelghani (Abdel) Omari as its first-ever Chief Financial Officer (CFO).
Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.
Beckman Coulter Diagnostics, a global leader in clinical diagnostics, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter's Access p‑Tau217/β-Amyloid 1-42 plasma ratio. This blood test is designed to aid healthcare providers identify patients with amyloid pathology associated with Alzheimer's disease.
Young Pharmaceuticals, Inc., a leading provider of physician-dispensed skincare products, announces an exclusive distribution agreement with LAC2βiome S.r.l., a maker of microbial based product solutions in Milan, Italy.