FDA Approval

The latest news regarding FDA applications, processes, and approval. This section contains releases regarding the Food and Drug Administration’s consideration of new products, drugs, therapies and treatments. Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and safety alerts.

Latest

Apr 09, 2024, 10:07 ET Texas Cardiac Arrhythmia Institute at St. David's Medical Center first in U.S. to use FDA-approved pulsed field ablation system

Electrophysiologists at the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center became the first in the nation to use a novel...

Apr 04, 2024, 08:05 ET Microbion's Topical Pravibismane Phase 1b Moderate or Severe Diabetic Foot Ulcer Infection Study is Published in International Wound Journal

Topical pravibismane was found to be safe and well-tolerated for all doses tested in subjects with moderate to severely infected, chronic diabetic...

Apr 02, 2024, 04:19 ET CONCEPT MEDICAL RECEIVES US FDA IDE APPROVAL FOR MAGICTOUCH AVF INDICATION, THEIR FIFTH US CLINICAL STUDY APPROVAL FOR THE MAGICTOUCH PORTFOLIO

Concept Medical has been granted 'IDE Approval' from the U.S. Food and Drug Administration (FDA) for MagicTouch AVF, its Sirolimus drug-coated...

Mar 28, 2024, 03:00 ET Vafseo® approved by the U.S. FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients

CSL Vifor is pleased that its partner Akebia Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo...

Mar 27, 2024, 08:00 ET Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has...

Mar 20, 2024, 09:00 ET Enhancing National Preparedness: Rafa Laboratories Partners with BARDA to Advance the Development of a new design for Rafa's Pediatric Atropine Autoinjectors

Rafa Laboratories, LTD., a leading manufacturer of Emergency Medical Solutions, and the Biomedical Advanced Research and Development Authority...

Feb 28, 2024, 07:00 ET First product based on LTS Sorrel™ wearable drug delivery platform launched in the US

LTS LOHMANN Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company, announced today that its customer Coherus BioSciences, Inc...

Feb 15, 2024, 10:15 ET Curadev's Differentiated Next Generation STING Agonist CRD3874-SI

Curadev is excited to introduce CRD3874, a first-in-class allosteric small molecule STING agonist, with distinct pharmacological properties that...

Feb 14, 2024, 10:39 ET Numinus Wellness Inc. Congratulates Lykos Therapeutics on FDA Acceptance of New Drug Application for MDMA-Assisted Therapy for PTSD

Numinus Welcomes Psychedelic Pioneer, Rick Doblin, Ph.D., as Strategic Adviser Updates Market on Closing of Previously Announced Bought Deal /THIS...

Feb 13, 2024, 11:00 ET ONTARIO BRAIN INSTITUTE PORTFOLIO COMPANY RECEIVES FDA CLEARANCE FOR INNOVATIVE DEPRESSION TECHNOLOGY

TORONTO, Feb. 13, 2024 /CNW/ - Pioneering a new approach to treat depression, NeuroQore, Inc. – a neurotechnology company supported by the Ontario...

Jan 24, 2024, 10:37 ET FDA purchases digiM I2S software for the assessment of product quality attributes

The U.S. Food and Drug Administration has placed a purchase order (75F40123P00369) committing to an annual subscription of digiM I2S, a fully...

Jan 23, 2024, 05:00 ET FDA Grants Breakthrough Device Designation to Amadix´s preventive screening blood test for Colorectal Cancer

Amadix, a Spanish biotech company, announced today that PreveCol®, its colorectal cancer screening blood test, has received Breakthrough Device...

Jan 16, 2024, 08:30 ET Health Canada Approves UPLIZNA® (inebilizumab for injection) for the Treatment of Neuromyelitis Optica Spectrum Disorders (NMOSD)

-- First and only anti-CD19 B-cell-depleting monotherapy for the treatment of adult patients with NMOSD who are anti-aquaporin-4 immunoglobulin G...

Jan 11, 2024, 07:00 ET U.S. FDA Approves the VISUMAX 800 with SMILE pro software from ZEISS

Carl Zeiss Meditec AG -- ZEISS Medical Technology announced today that the U.S. Food and Drug Administration (FDA) has approved the VISUMAX® 800 with ...

Jan 09, 2024, 08:45 ET Natural Cycles receives approval from Health Canada for its birth control app

Natural Cycles, the leading women's digital health company, announced it has received approval from Health Canada to market and sell the Natural...

Jan 05, 2024, 13:35 ET QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) Receives USFDA 510(k) Clearance

QDOSE® Multi-purpose Voxel Dosimetry Software (Personalized Dosimetry in Molecular Radiotherapy) received USFDA 510(k) clearance in August 2023....

Jan 03, 2024, 10:00 ET FDA Grants Breakthrough Device Designation for Geneseeq's Multi-cancer Early Detection Solution

TORONTO, Jan. 3, 2024 /CNW/ - Geneseeq announced that its multi-cancer early detection solution, CanScan™, has been granted Breakthrough Device...

Dec 04, 2023, 11:00 ET LITFULO™ Receives Health Canada Approval, Becoming the First Approved Treatment for Severe Alopecia Areata in Canada.

A dual JAK3/TEC inhibitor, LITFULO™ (ritlecitinib) is approved for adults and adolescents over 12 years of age for treatment of severe alopecia...

Nov 22, 2023, 08:00 ET Vaccine Partner Valneva receives FDA approval for the World's first chikungunya vaccine using Albumedix' Recombumin®

The FDA on 10th November 2023 announced the approval of IXCHIQ®, Valneva's vaccine against the chikungunya virus. Notably, this is the first vaccine...

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