Sunday, February 16, 2020

Sunday, February 16, 2020

Latest News

3D SYSTEMS: Expands its Industry-Leading Portfolio of Dental Materials with Newly FDA-Cleared NextDent® Denture 3D+

Dental labs and clinics can produce dentures 75% faster with 90% lower cost using 3D Systems' Digital Denture Workflow

WELLDOC, INC: Welldoc's Award-winning Digital Health Solution BlueStar Adds FDA-Clearance for Use in Type 1 Diabetes

This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes

U.S. FDA: Authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Today, the U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology.

U.S. FDA: Statement on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.

SURMODICS: The Surmodics Sundance™ Sirolimus-Coated Balloon Catheter Earns FDA Breakthrough Device Status

Sundance™ Sirolimus-Coated Balloon will receive prioritization throughout the FDA submission and review process to provide patients and physicians timely access to medical devices

CHUGAI PHARMACEUTICAL: EMA and FDA Accept Marketing Applications for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)

NMOSD is a rare disease where repeated relapses may result in visual impairment and motor disability in the course of disease progression

GENETECH: FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder

Satralizumab represents a potential new approach to treating neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating disease often misdiagnosed as multiple sclerosis (MS)

ALKERMES: Biogen and Alkermes Announce FDA Approval of VUMERITY™ (diroximel fumarate) for Multiple Sclerosis

VUMERITY, a New Oral Treatment Option for Relapsing Forms of MS, Offers a Combination of Well-Characterized Efficacy, Safety and Tolerability

ASTELLAS PHARMA: U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.

MEDICINE360: FDA Approves Medicines360's LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg to Prevent Pregnancy for up to Six Years, the Longest Approved Duration of Use of Any Hormonal IUDs

Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's Supplemental New Drug Application (sNDA) to extend the duration of use of LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg for the prevention of pregnancy for up to six years.

BLUEWILLOW: Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.

WOLFE EYE CLINIC: U.S. Food & Drug Administration Approves New Wet Age-Related Macular Degeneration Treatment

The highly anticipated approval of Beovu® (brolucizumab) may reduce the frequency of intravitreal injections for wet age-related macular degeneration patients following clinical trials at Wolfe Eye Clinic

ALZHEIMER'S ASSOCIATION: Statement Biogen to Submit Aducanumab Results in Early Alzheimer's to U.S. FDA

On behalf of the more than 5 million Americans living with Alzheimer's and their family members, the Alzheimer's Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose.

FDA Health News