Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival (OS) compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer (nmCRPC) the opportunity to extend their lives
CognitOss is designed to treat osteomyelitis, a debilitating inflammatory bone infection
Concentrated molybdenum-98 (cMo-98) enables up to four-fold increase of critical medical radioisotope Mo-99 production in U.S.
King & Spalding announced that Marisa Maleck rejoins the firm as a partner in the FDA and Life Sciences team, which is part of the Government Matters practice.
Functional Neuromodulation announced today that it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for the Vercise™ Deep Brain Stimulation (DBS) Systems, developed and manufactured by Boston Scientific Corporation, in the treatment of patients 65 years and older with mild probable Alzheimer's disease.
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced today that the U.S. Food and Drug Administration (FDA) accepted priority review for its New Drug Application (NDA) for mirabegron for oral suspension and its supplemental New Drug Application (sNDA) for Myrbetriq® (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older.
EchoGo Pro is an AI service for automated identification of coronary artery disease
JustKN95Masks.com (https://justkn95masks.com/) announced that its warehouse was fully stocked with over 250,000 FDA-registered, fully certified KN95 respirators to help meet the growing demand for face masks in the United States.
Forge Biologics has received IND, IBC, and IRB clearance for FBX-101, a gene therapy for patients with Krabbe disease, a rare and fatal genetic disorde
LexaGene Holdings, Inc., (TSX-V: LXG; OTCQB: LXXGF) (the “Company”), a molecular diagnostics company that develops fully automated rapid pathogen detection systems, is pleased to announce that it has started a series of studies required by the FDA for Emergency Use Authorization (EUA) testing for its COVID-19 assay in a point-of-care (POC) environment using its fully automated MiQLab™ system.
VisionQuest Biomedical Inc. (VisionQuest) announced today that the company has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market the Image Quality Analyzer (IQA) software, which reduces unreadable images captured in teleretinal screening programs by retinal photographers.
Turn Therapeutics, a noted innovator in advanced wound care, announced it has received positive data for its absorbent, antimicrobial regenerative wound matrix, known internally as Flex Antimicrobial.
LyGenesis, Inc., a biotechnology company developing cell therapies that enable organ regeneration, announced today that the U.S Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application.
Interscope, Inc. and Micro-Tech Endoscopy signed a partnership agreement focused on the distribution of Interscope's unique EndoRotor System for gastroenterology.
The following quote is attributed to Amber McCoig, D.V.M., M.P.H., deputy director of the FDA's Center for Veterinary Medicine (CVM) Division of Compliance
Sustained acoustic medicine (SAM) technology, approved by the FDA in 2013 for clinical utilization, sees re-approval for expanded indications in 2020.
The following quote is attributed to Jeffrey Shuren M.D., J.D., director of FDA's Center for Devices and Radiological Health
FDA Sets PDUFA Target Action Date of June 1, 2021
Heru, Inc., a 3 Seasons Capital, LLC portfolio medical technology company, has received Class 1 listing with the U.S. Food and Drug Administration (FDA) registration for developing a next-generation, artificial intelligence (AI)-driven platform for vision diagnostics and augmentation. Heru is the first diagnostic application for visual field exams.
