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…
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…
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…
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…
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,…
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…
While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public…
DRIVEWIRE™ provides efficient access in difficult neuro and peripheral vascular procedures
The First and Only System Designed and Indicated for DEN now Available in the United States and Europe
Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders,…
Agency authorized first device indicated to treat patients with necrotic tissue resulting from complications of acute pancreatitis
Sign-up for the Weekly Newsletter from FDA Reporter.
