Thursday, March 28, 2024

Thursday, March 28, 2024

Latest News

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 (nmCRPC) the opportunity to extend their lives

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 Boston Scientific Corporation, in the treatment of patients 65 years and older with mild probable Alzheimer's disease.

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 Drug Application (sNDA) for Myrbetriq® (mirabegron) tablets for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older.

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 Authorization (EUA) testing for its COVID-19 assay in a point-of-care (POC) environment using its fully automated MiQLab™ system.

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 retinal photographers.

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

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 the first diagnostic application for visual field exams.

FDA Reporter