Blueprint Medicines Corporation announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKIT® (avapritinib) for the treatment of adults with indolent systemic mastocytosis (ISM). All U.S. patients with ISM now have access to the first and only approved medicine designed to treat their disease.
Abbott announced its Assert-IQ™ insertable cardiac monitor (ICM) has received U.S. Food and Drug Administration (FDA) clearance, giving physicians a new option for diagnostic evaluation and long-term monitoring of people experiencing irregular heartbeats.
Sintetica S.A., an international pharmaceutical company with manufacturing facilities in Switzerland, announces the launch of Lidocaine Hydrochloride Injection, USP 1%, 2% and 4% through its subsidiary Sintetica US.
Anton Jorgensen, MD and Ortho San Antonio has announced the first cases in the BalancedBack Total Joint Replacement pivotal clinical trial using the breakthrough 3Spine MOTUS device, as an alternative to lumbar spinal fusion surgery. Dr. Jorgensen completed the surgeries at the Foundation Surgical Hospital of San Antonio.
Nexus Pharmaceuticals, Inc. has announced that it has received US Food and Drug Administration (FDA) approval for EMERPHED® (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes. The 10mL presentation is the first and only FDA-approved ready-to-administer 10mL pre-filled syringe available.
Fresenius Kabi had announced the immediate availability in the U.S. of Stimufend® (pegfilgrastim-fpgk), the company’s biosimilar to Neulasta® (pegfilgrastim), for use in patients at risk for febrile neutropenia, a common side effect of many anti-cancer medications. Stimufend is available in a single-dose, pre-filled syringe that delivers 6mg/0.6mL solution for subcutaneous injection.
Syqe Medical, the developer of innovative technologies in the world of medical devices, is pleased to announce the signing of an agreement with the Israeli Ministry of Defence to supply the SyqeAir Inhaler and Cartridges to all veterans prescribed medical cannabis by inhalation through the company's ground-breaking platform.
PureTech Health plc a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, had announced that it will advance LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (PPD).
Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform.
RSIP Neph (part of the RSIP Vision group) its new innovative intra-op solution that utilizes advanced Computer Vision and Artificial Intelligence algorithms, to enhance the next generation of robotic surgery.