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

Jun 19, 2019, 09:18 ET ReNetX Bio, Inc. Announces U.S. FDA Authorization to Proceed for IND Application to Treat Patients with Chronic Spinal Cord Injury

ReNetX Bio, Inc., a leading biotechnology company committed to reversing disease and damage for patients suffering from central nervous system...


Jun 19, 2019, 06:00 ET CARsgen Therapeutics Receives IND Clearance for BCMA-CAR-T Cells from the U.S. FDA

CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, today announced that...


Jun 17, 2019, 17:41 ET FDA approves Victoza® for the treatment of type 2 diabetes in children and adolescents aged 10-17 years

Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza® (liraglutide)...


Jun 17, 2019, 16:16 ET Eiger Announces Breakthrough Therapy Designation Granted by FDA for Avexitide for Treatment of Post-Bariatric Hypoglycemia (PBH)

Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare and ultra-rare...


Jun 17, 2019, 15:26 ET FDA approves new treatment for pediatric patients with type 2 diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type...


Jun 17, 2019, 10:58 ET Third FDA Clearance for Zebra-Med's AI Solution for Brain Bleeds Alerts

Zebra Medical Vision (https://www.zebra-med.com/), the deep learning medical imaging analytics company, announces today that it has received its...


Jun 17, 2019, 09:15 ET FDA Grants Breakthrough Device Designation To Bio-Techne's ExoDx™ Prostate IntelliScore™ (EPI) Test

Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate...


Jun 17, 2019, 07:04 ET FDA approves new cochlear implant with easier access to MRI and expanded connectivity ready for Google's direct streaming to Android smartphones

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, today announced the U.S. Food and Drug Administration's (FDA)...


Jun 14, 2019, 07:30 ET Ampio Regulatory and Clinical Update

Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) announced today that it received FDA approval of the Company's special protocol assessment (SPA) of a...


Jun 13, 2019, 19:13 ET FDA Approves Amgen And Allergan's KANJINTI™ (trastuzumab-anns), A Biosimilar To Herceptin® (trastuzumab)

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™...


Jun 12, 2019, 10:46 ET eMurmur receives CE mark certification for its heart murmur detection solution

eMurmur ID enables healthcare providers to detect and classify heart murmurs with expert-level accuracy OTTAWA, June 12, 2019 /PRNewswire/ - eMurmur® ...


Jun 12, 2019, 09:00 ET Bolder BioTechnology Announces FDA Orphan Drug Designation for BBT-059 for Acute Radiation Syndrome

Bolder BioTechnology, Inc. announced today that its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the Food and Drug...


Jun 11, 2019, 16:05 ET Aratana Therapeutics Granted FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) 10 mL Vial

Aratana Therapeutics, Inc. (Nasdaq: PETX), a pet therapeutics company focused on the development and commercialization of innovative therapeutics for ...


Jun 11, 2019, 14:32 ET EmCyte Announces FDA 510(k) Clearance for its PureBMC® Supraphysiologic Concentrating System

EmCyte, is proud to announce that it has received FDA 510(k) clearance for its PureBMC® Supraphysiologic Concentrating System. The system's 510(k)...


Jun 11, 2019, 10:00 ET CorMatrix® Cardiovascular, Inc. receives FDA 510(k) clearance to market the Cor™ PATCH epicardial patch for tissue support and repair in adult patients

CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA 510(k)...


Jun 11, 2019, 09:00 ET AI for C-Spine Fractures: Aidoc Sets the Pace With 3rd FDA Clearance in 9 Months

Aidoc, the leading provider of AI solutions for radiologists, today announced that the Food and Drug Administration (FDA) has cleared the world's...


Jun 10, 2019, 11:54 ET FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy...


Jun 07, 2019, 13:31 ET PTC Therapeutics Receives FDA Approval for the Expansion of the EMFLAZA® (deflazacort) Labeling to Include Patients 2-5 Years of Age

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental New Drug...


Jun 06, 2019, 11:19 ET Exeltis USA, Inc. Announces the Approval of Slynd™, the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window

Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced today that the US Food and Drug Administration (FDA) has...


Jun 06, 2019, 11:07 ET Akonni Biosystems Receives FDA 510(k) Clearance of Its TruDiagnosis Multiplex Diagnostic System

Akonni Biosystems Inc. announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for its TruDiagnosis® System....


Jun 05, 2019, 15:00 ET Effects of Ospemifene on Genitourinary Health: Prospective Vulvar-Vestibular Photography and Direct Assessments in Post-Menopausal Women

ROSEMONT, PA, June 5, 2019 /PRNewswire/ - Duchesnay Inc., a pharmaceutical company specializing in women's health, is pleased to announce the...


Jun 05, 2019, 07:27 ET bFed™ System FDA Regulatory Clearance The First Tube Feeding Delivery System Available Over the Counter

U Deliver Medical, LLC announced they have received Food and Drug Administration (FDA) 510(k) regulatory clearance for The bFed™ System tube feeding...


Jun 04, 2019, 21:01 ET FDA Approves Emgality® (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality® (galcanezumab-gnlm)...


Jun 04, 2019, 16:50 ET FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks

The U.S. Food and Drug Administration today approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster...


Jun 04, 2019, 16:30 ET FDA Issues Clearance for the ReStore™ Exo-Suit, the First Soft Robotic System for Stroke Therapy

ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading manufacturer of robotic medical devices for individuals with lower limb...