BAYER: U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information
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…
LOCATE BIO: CognitOss Granted FDA Breakthrough Device Designation
CognitOss is designed to treat osteomyelitis, a debilitating inflammatory bone infection
NORTHSTAR MEDICAL RADIOISOTOPES: Announces FDA Approval for Enhanced U.S. Mo-99 Radioisotope Production Capacity
Concentrated molybdenum-98 (cMo-98) enables up to four-fold increase of critical medical radioisotope Mo-99 production in U.S.
KING & SPALDING: FDA and Life Sciences Team Adds Partner in Washington
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: Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer’s Disease
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…
ASTELLAS PHARMA INC.: FDA Accepts for Priority Review the New Drug Application for mirabegron for Oral Suspension and Supplemental New Drug Application for Myrbetriq® (mirabegron) Tablets in Pediatric Patients
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…
ULTROMICS: Receives Fda Clearance for a First-of-kind Solution in Echocardiography to Help Clinicians Diagnose Disease
EchoGo Pro is an AI service for automated identification of coronary artery disease
JUSTKN95MASKS.COM: Offers FDA-Approved KN95 Masks for Bulk and Wholesale Orders – Just in Time for President-Elect Biden’s Upcoming U.S. Face Mask Mandate
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: Announces FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Trial (RESKUE) of FBX-101 Gene Therapy for Patients with Krabbe Disease
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: Starts FDA EUA Study for Point-of-Care COVID-19 Testing
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…
VISIONQUEST BIOMEDICAL INC.: Gains FDA 510(k) Clearance for the Image Quality Analyzer Software
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…
TURN THERAPEUTICS: To File for FDA Clearance of Absorbent, Antimicrobial, Biologic Wound Matrix
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: Receives FDA Clearance to Begin Phase 2a Trial of its Cell Therapy for Patients with End Stage Liver Disease, and also Closes $11 Million Convertible Debt Financing
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.
Micro-Tech Endoscopy and Interscope Announce Partnership & Extended FDA Clearance for EndoRotor® System
Interscope, Inc. and Micro-Tech Endoscopy signed a partnership agreement focused on the distribution of Interscope’s unique EndoRotor System for gastroenterology.
FDA: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin
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
ZETROZ: Systems’ Wearable Ultrasound Device, SAM, Receives Expanded FDA Re-Approval, Positioning the Company for Market Growth in 2021
Sustained acoustic medicine (SAM) technology, approved by the FDA in 2013 for clinical utilization, sees re-approval for expanded indications in 2020.
FDA: Takes Additional Actions to Increase the Safety of Laparoscopic Power Morcellators Used in Gynecologic Surgeries
The following quote is attributed to Jeffrey Shuren M.D., J.D., director of FDA’s Center for Devices and Radiological Health
ALKERMES: FDA Accepts Alkermes’ Resubmission of New Drug Application for ALKS 3831
FDA Sets PDUFA Target Action Date of June 1, 2021
3 SEASONS CAPITAL LLC: Heru, Inc., A 3 Seasons Capital, LLC Portfolio Medical Technology Company, Receives Class 1 Listing With the FDA for Developing a Next-Generation, Artificial Intelligence (AI)-Driven Platform for Vision Diagnostics and Augmentation
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…