Monday, March 30, 2020

Monday, March 30, 2020

Latest News

CEPHEID: Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test

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.

ABBOTT: Receives FDA Emergency Use Authorization and Launches Test to Detect Novel Coronavirus

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.

COMPANION MEDICAL: FDA Clears InPen Diabetes Management System for Fixed Dosing and Meal Estimation

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.

U.S. FDA: FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

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.

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).

ORTHOFIX: Announces FDA Approval of STIM onTrack 2.1 Mobile App for Bone Growth Stimulators

App designed to facilitate patient compliance and improve outcomes now captures Patient Reported Outcome Measures

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: Breakthrough Device Designation Received From the FDA for EndoArt®

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: 'Green' Medical Propellant Receives FDA Approval to Proceed to Clinical Trials

Koura's Zephex® 152a facilitates greater than 90% reduction in inhaler carbon footprints compared to current MDIs

HONEST GLOBE: Elixicure CBD-Infused Pain Relief Product Listing Receives FDA Certification

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.

FDA Reporter