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Two new medicines, Vyndaqel and Vyndamax, were approved for adults by the Food and Drug Administration earlier this month. They will help to treat heart disease caused by transthyretin mediated amyloidosis (ATTR-CM).
Innovative external fixator shortens surgical time, simplifies inventory, and enhances patient care.
IDLogiq® innovations have been selected by the Food and Drug Administration (FDA) for the Pilot Project Program under the Drug Supply Chain Security Act (DSCSA) to prototype and develop a system that can address the national security of the drug supply chain and future interoperability of secure electronic information exchange.
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OrSense Ltd., a leading developer of systems for non-invasive measurements of Hemoglobin, today announces that its NBM200 non-invasive Hemoglobin measurement device has received FDA/CBER 510(K) clearance for use in blood banks
Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the medical indication of its TEG® 6s Hemostasis Analyzer System for use in adult trauma settings.
Terminally and chronically ill patients should not be charged for “right to try” treatments, a health-care policy adviser for an Illinois-based free-market think tank, speaking as “a health-care consumer,” said during a recent interview.
NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) today announced that the US Food and Drug Administration, FDA, has approved NeuroVive's IND (Investigational New Drug) application, enabling clinical studies in the US with the company's drug candidate NeuroSTAT in development for treatment of moderate to severe traumatic brain injury, TBI.
As the matter of prescription drug prices continues to generate debate, and some federal government action, one consumer advocate is warning the Food and Drug Administration (FDA) has loosened rules over interactions between physicians and pharmaceutical companies.
SafeTraces, Inc. announced that the U.S. Patent and Trademark Office granted the company a U.S. Patent titled DNA Based Bar Code for Improved Food Traceability.
The U.S. Food and Drug Administration approved 438 drug products in April, according to an online list the agency updated this week.
The first generic version of Penicillamine Capsules USP is now approved in the U.S.
Legislation that would allow terminally ill patients to access stem cell treatments not yet signed off by the U.S. Food and Drug Administration now is in the North Carolina state Senate after unanimously passing the House last week.
OnKure, Inc., the epigenetics-focused drug discovery and development company that is advancing the first Largazole-derived, histone deacetylase inhibitor into Phase 1 clinical trials, announced that its lead drug, OKI-179, has cleared the FDA IND regulatory hurdle to start Phase 1 trials.
Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial.
LENSAR® Laser System with Streamline® IV Capabilities Expands to Include Micro Radial Incisions, Allowing Surgeons to Treat Additional Corneal Conditions
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR).
