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Tag: U.S. Food and Drug Administration

Cordance Medical’s NeuroAccess Receives FDA Breakthrough Device Designation for Liquid Biopsy in Brain Tumors | BioSpace

Transforming the Landscape of Neuro-Oncology Diagnostics Through Non-Invasive Blood-Brain Barrier Opening MOUNTAIN VIEW, Calif., Oct. 26, 2023 /PRNewswire/ -- Cordance Medical, a pioneering medical...

How an Algorithm Could Help Improve Blood Transfusions

A blood transfusion involves donating, collecting, storing, testing and delivering blood to a person in need. Transfusions save countless lives yearly, and improving the...

Understanding FDA Registered vs Cleared vs Approved vs Granted for Medical Devices – RegDesk

This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential...

ZKR Orthopedics announces FDA Breakthrough Device designation for the LIFT Implant Technology | BioSpace

KENTFIELD, Calif., Oct. 09, 2023 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, today announced that its LIFT implant technology...

Obesity drug success sparks biotech buying spree

The last few months have seen the obesity drug market soar, after new weight loss and diabetes drugs like Novo Nordisk’s Wegovy and Ozempic...

FDA and Clinical Trials Industry Experts Focus New Attention on Rare Disease Studies – ACRP

With the recent launch of the U.S. Food and Drug Administration’s (FDA’s) Rare Disease Endpoint Advancement (RDEA) Pilot Program, the clinical research enterprise gains...

More good news for pediatric RSV immunizations

On September 22, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted 11-1 to recommend one dose of...

“LEQEMBI Intravenous Infusion” (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan

TOKYO and CAMBRIDGE, Mass., Sept 25, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated...

US FDA Approves Jardiance for the Treatment of Adults with Chronic Kidney Disease

RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 22, 2023 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Jardiance® (empagliflozin) 10 mg tablets to...

U.S. approval for psychedelic drug MDMA nears after success in clinic

The psychedelic drug MDMA edges closer towards FDA approval for the treatment of post-traumatic stress disorder (PTSD) in the U.S., after promising results of...

FDA Alert: VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 22, 2023Audience: Health Professional, Pharmacy, ConsumerSeptember 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension,...

Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)

Generic name: budesonideTreatment for: Eosinophilic EsophagitisTakeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis...

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