Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® system with Persona™ technology.
BD FACSDuet™ Sample Preparation System, now available in the U.S., as the first fully automated sample-to-answer solution when integrated with the BD FACSLyric™ Flow Cytometer
2nd Investigational Gene Therapy in Clinic, Potential 3rd Therapy in PKU Franchise, 15+ Year Commitment to PKU Community
Announced engaging Saul Kaye the founder of iCAN (www.israel-cannabis.com) and CannaTech (www.canna-tech.co) to provide an independent review of PAOG's RespRx research for the treatment of Chronic Obstructive Pulmonary Disease (COPD), and to help prepare RexpRx for engaging with a contract research organization (CRO) to advance an investigational New Drug application (IND) with the Food and Drug Administration (FDA).
The United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) outlining strengthened coordination between the FDA and the USDA’s Agricultural Marketing Service (AMS) and Foreign Agricultural Service (FAS) to facilitate the export of milk and milk products from the United States. U.S. dairy exports are valued at nearly $6 billion annually.
The U.S. Food and Drug Administration issued the final guidance, “Breast Implants - Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the information available to patients and health care professionals about the risks of breast implants.
Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).
CapsoVision, an innovator in the gastroenterology diagnostics market, announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration.
We proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the “intended use” of a product.
The U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests.
Jointechlabs – a leader in point-of-care regenerative medicine therapies – announced that the U.S. Food and Drug Administration (FDA) cleared the company's MiniTC™ for point-of-care fat tissue processing designed to obtain microfat (or fat grafts), for multiple indications.
Berubicin Previously Received FDA Orphan Drug Designation
The U.S. Food and Drug Administration (FDA) is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.
The U.S. Food and Drug Administration issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
LumiraDx, the next-generation point of care diagnostic company, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the LumiraDx SARS-CoV-2 antigen test, which will help meet the global challenge of delivering fast and cost-efficient COVID-19 tests in community care settings.
The National Industrial Hemp Council (NIHC) filed comments with the Food And Drug Administration (FDA) to help direct their work on establishing a policy of enforcement discretion on CBD products.
Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of glioblastoma, the most common and most aggressive form of primary brain