"The FDA continues to seek new ways to advance science to address the public health challenges that families and communities across the country face," said...
The FDA clearance also includes the company's core technology platform, the proprietary AXINON® System, that incorporates diagnostic testing algor...
Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorb...
Regulatory Designation Includes Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis and Post-Polycythemia Vera Myelofibrosis – &ndas...
In addition, Melinta and BARDA will partner on the development of BAXDELA® against biothreat pathogens. Under this contract, BARDA has awarded $20.5M f...
The advanced and FDA-cleared Magstim Horizon 3.0 transcranial magnetic stimulation (TMS) system is now UKCA registered and available for sale in the UK, pr...
The Centers for Medicare & Medicaid Services (CMS) announced broader Medicare coverage of LEQEMBI Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Nai...
Designation confers advantages including marketing exclusivity and tax credits Padeliporfin VTP Phase 1 trial in Pancreatic cancer to start b...
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has approved NGENLA (somatrogon...
In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy...
The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted in...
U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedeli...
Validation is a required component of medical device quality assurance. But device manufactures new to CMMs find it challenging to validate the software an...
Under the adaptive statistical analysis plan, should the CardiAMP Cell Therapy for Heart Failure study be stopped early for anticipated efficacy at this, o...
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