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

Oct 21, 2020, 08:17 ET FLEX Vessel Prep™ System Receives New Indication to Address In-Stent Restenosis

VentureMed Group, Inc. (VentureMed), a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral...


Oct 21, 2020, 08:00 ET Scopio Labs Receives FDA Clearance for its AI-Powered Full Field Peripheral Blood Smear (Full Field PBS) Application

Scopio Labs, a leading provider of Full Field Morphology (FFM), announced today that it was granted FDA clearance to market and sell its X100 with...


Oct 21, 2020, 07:45 ET Acuitive Technologies Granted FDA 510(k) Clearance for CITREGEN™ CITRELOCK™ Tendon Interference Screw System

Acuitive Technologies today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the CITRELOCK™...


Oct 21, 2020, 07:30 ET Tyber Medical Receives FDA Clearance on Foot and Ankle Plating Systems

Tyber Medical, LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine...


Oct 20, 2020, 10:56 ET PAOG FDA Application Process For Respiratory Cannabis Drug Treatment Update Scheduled This Friday

PAO Group, Inc. (USOTC: PAOG) today announced the company plans to release a new key update this Friday, October 23, 2020, on its progress to advance ...


Oct 20, 2020, 09:00 ET Ezra Receives FDA Clearance For Prostate Cancer Artificial Intelligence

Ezra, the NY-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) premarket authorization for ...


Oct 20, 2020, 08:00 ET U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration...


Oct 20, 2020, 07:00 ET Ezra Receives FDA Clearance for Prostate Cancer Artificial Intelligence

Ezra, the New York-based startup transforming early cancer screening using MRI, announced today that it has received FDA 510(k) clearance for its...


Oct 19, 2020, 09:00 ET Neurelis Announces FDA Approval Of Extended Expiration Dating For VALTOCO® (Diazepam Nasal Spray)

Neurelis, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted extended expiration dating for the company's lead...


Oct 19, 2020, 08:00 ET FDA Approves New Container System for Peritoneal Dialysis Solutions

Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that DELFLEX® peritoneal dialysis solutions in Biofine®, an...


Oct 19, 2020, 02:51 ET Oncopeptides has submitted an Investigational New Drug application to FDA for the second drug candidate from the PDC platform

Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U....


Oct 16, 2020, 19:34 ET VENCLEXTA® (venetoclax) Receives FDA Full Approval for Acute Myeloid Leukemia (AML)

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in...


Oct 16, 2020, 14:31 ET USA Vape Lab Receives FDA Premarket Tobacco Product Application (PMTA) Filing Letter

USA Vape Lab, the manufacturer behind the premium e-liquid brand NAKED 100®, announced that it received its filing letter from the Food and Drug...


Oct 15, 2020, 13:59 ET LIVMOR receives FDA clearance for the world's first prescriptible wearable for continuous heart monitoring

LIVMOR, Inc., a leading digital health solutions company, announced today that the Company received FDA 510(k) clearance for the LIVMOR Halo™ AF...


Oct 15, 2020, 11:05 ET PAOG Expects To Finalize CRO Engagement For Cannabis Drug Within Next Two Weeks

PAO Group, Inc. (USOTC: PAOG) today published a progress update on the company's ongoing initiative to advance an investigational New Drug...


Oct 15, 2020, 11:00 ET Genalyte Obtains FDA Emergency Use Authorization for Rapid COVID-19 Antibody Test

Genalyte, a leading point-of-care diagnostics and analytics company, announced today its SARS-CoV-2 Multi-Antigen Serology Panel has received...


Oct 15, 2020, 09:00 ET Mölnlycke launches new skin-friendly Biogel® surgical gloves to reduce the risk of allergic contact dermatitis for surgeons and nurses

Mölnlycke is celebrating World Handwashing Day with the launch of the innovative Biogel® PI UltraTouch® S surgical glove, which addresses the problem ...


Oct 15, 2020, 08:00 ET entrinsic bioscience Secures U.S. Patent Grant for Breakthrough Respiratory Disease Program

entrinsic bioscience (EBS), a company pioneering a next generation protein modulation technology, today announced that it has been granted U.S....


Oct 15, 2020, 07:48 ET Seattle Gummy Company Secures The First (IND) Gummy Drug Approval From FDA

Seattle Gummy Company's breakthrough gummy drug program, which delivers Active Pharmaceutical Ingredients (APIs) in its innovative gummy matrix,...


Oct 15, 2020, 07:30 ET Armata Pharmaceuticals Announces Clearance of Investigational New Drug (IND) Application to Initiate Phase 1b/2a Clinical Trial of Lead Candidate AP-PA02 in Pseudomonas aeruginosa Infections

Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on precisely targeted bacteriophage...


Oct 15, 2020, 07:00 ET Apexigen's APX005M Granted Orphan Drug Designations for the Treatment of Esophageal and Gastroesophageal Junction Cancer and for the Treatment of Pancreatic Cancer

Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for...


Oct 15, 2020, 04:00 ET Mölnlycke launches new skin-friendly Biogel® surgical gloves to reduce the risk of allergic contact dermatitis for surgeons and nurses

Mölnlycke is celebrating World Handwashing Day with the global launch of the innovative Biogel® PI UltraTouch® S surgical glove, which addresses the...


Oct 14, 2020, 17:42 ET Regeneron's Antibody Cocktail REGN-EB3 (Inmazeb®) is First FDA-Approved Treatment for Ebola (Zaire Ebolavirus)

In a large clinical trial, Inmazeb showed superiority compared to other investigational agents (ZMapp and remdesivir) with respect to mortality;...


Oct 14, 2020, 17:35 ET FDA Approves First Treatment for Ebola Virus

Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal...


Oct 14, 2020, 08:05 ET Harmony Biosciences Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative...