Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing COVID-19.
BIOSTAGE: Announces IND Approval from FDA for its Lead Product Candidate Cellspan™ Esophageal Implant
Biostage, Inc. (OTCQB: BSTG) (Biostage or the Company), a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug application (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal disease that require a segmental surgical resection to repair the diseased tissue.
The test will be used on the company's m2000 RealTime system that is currently available in hospitals and molecular laboratories in the U.S.
NOVADOZ PHARMACEUTICALS: Increases Presence in the Generic Oncology Market with an FDA Approval of Thiotepa 15mg &100mg Vials for Injection
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.
PUROLITE: Protein A Chromatography Resin Implemented Into FDA-approved Commercial Manufacturing of Monoclonal Antibody Treatments
Purolite Ltd., a leading manufacturer of resin-based separation, purification and extraction technologies, today announces that Praesto® Jetted A50, an agarose-based Protein A chromatography resin, has been incorporated into the commercial manufacturing process of an FDA-approved monoclonal antibody treatment by one of the world's leading contract manufacturing organizations.
Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose according to the 2019 Seagrove Partners' Patients Perspectives Report.
The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch.
BLUEGRASS VASCULAR TECHNOLOGIES: FDA Grants De Novo Clearance to Bluegrass Vascular Technologies for the Surfacer® Inside-Out® Access Catheter System
First device to reliably and repeatedly achieve central venous access from the inside-out in patients with venous obstructions
SOLIGENIX: FDA Grants Soligenix "Fast Track" Designation for RiVax® in the Prevention of Ricin Poisoning
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).
App designed to facilitate patient compliance and improve outcomes now captures Patient Reported Outcome Measures
Novel MRI system is a breakthrough in patient accessibility and cost
BAXTER INTERNATIONAL: Baxter and COSMED Announce U.S. FDA 510(k) Clearance of Q-NRG+ Indirect Calorimetry Device
Baxter International Inc. (NYSE: BAX), a global leader in clinical nutrition, today announced the U.S. Food and Drug Administration (FDA) clearance of Q-NRG+, a metabolic monitoring device utilizing indirect calorimetry (IC) technology.
INTERNATIONAL ISOTOPES INC.: Announces U.S. Food And Drug Administration Approval Of Their ANDA For Sodium IODIDE I-131
International Isotopes Inc. (OTCQB: INIS) (the "Company") is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA) for its SODIUM IODIDE I-131 pharmaceutical product.
EyeYon medical Ltd. announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its EndoArt®, Artificial Endothelial Layer Implant.
CAPTION HEALTH: FDA Grants Caption Health Landmark Authorization for First AI-Guided Image Acquisition System
Caption Guidance™ uses artificial intelligence to empower medical professionals without specialized training to perform cardiac ultrasound
Koura's Zephex® 152a facilitates greater than 90% reduction in inhaler carbon footprints compared to current MDIs
Elixicure's Over-The-Counter Drug Registration has been Certified by the U.S. Food and Drug Administration (FDA) for its Elixicure CBD-Infused Pain Relief products following a successful year-long process, announced Elixicure Chief of Business Development Yaniv Kotler.