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 19, 2018, 05:00 ET OBI Pharma Announces FDA Clearance of OBI-3424 IND Application for A Phase I/II Study Targeting AKR1C3 Solid Tumors

OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has cleared an...


Apr 19, 2018, 05:00 ET OBI Pharma erhält FDA-Genehmigung für IND-Antrag auf Phase-I/II-Studie zu OBI-3424 bei AKR1C3-exprimierenden soliden Tumoren

Erste klinische Studie zur Prüfung der Sicherheit und Wirksamkeit eines neuartigen zielgerichteten First-in-Class-Therapeutikums (kleinmolekulares...


Apr 19, 2018, 05:00 ET OBI Pharma annonce l'approbation par la FDA de sa demande de DNR pour une étude de phase I/II de l'OBI-3424 dans le traitement des tumeurs solides exprimant l'enzyme AKR1C3

Première étude clinique testant la sécurité et l'efficacité d'une thérapie ciblée innovante (promédicament à petites molécules) qui libère de...


Apr 18, 2018, 19:17 ET Roche expands indication for cobas® EGFR Mutation Test v2 as a companion diagnostic with TAGRISSO®

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its...


Apr 18, 2018, 19:06 ET US FDA Approves TAGRISSO® (osimertinib) As 1st-Line Treatment For EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for the 1st-line treatment of...


Apr 18, 2018, 17:37 ET Arthrosurface Gains FDA Clearance of OVOMotion™ Shoulder Arthroplasty System

Arthrosurface® announced today that The Company received FDA 510(k) Clearance to market the OVOMotion™ Shoulder Arthroplasty System. This stemless...


Apr 18, 2018, 09:00 ET Cantel Medical Receives FDA 510(k) Clearance to Market ADVANTAGE PLUS® Pass-Thru Automated Endoscope Reprocessor

Cantel Medical Corp. (NYSE: CMD) announced today that it has received U.S. Food and Drug Administration (FDA) 510 (k) clearance for its ADVANTAGE...


Apr 18, 2018, 08:30 ET ANI Pharmaceuticals Announces Approval of Morphine Sulfate Oral Solution

ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration ("FDA")...


Apr 18, 2018, 03:36 ET NeuroVive's KL1333 Receives FDA Orphan Drug Designation for Treatment of Mitochondrial Diseases

NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF), the mitochondrial medicine company, today announced that it has been granted...


Apr 17, 2018, 16:51 ET Rigel Announces FDA Approval of TAVALISSE™ (fostamatinib disodium hexahydrate) for Chronic Immune Thrombocytopenia (ITP) in Adult Patients

Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) approved TAVALISSE™ (fostamatinib...


Apr 17, 2018, 13:28 ET FDA approves first therapy for rare inherited form of rickets, x-linked hypophosphatemia

The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and...


Apr 17, 2018, 08:00 ET FDA Provides Full Approval to Praxbind, Specific Reversal Agent for Pradaxa

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind® (idarucizumab), the...


Apr 17, 2018, 07:00 ET King-Devick technologies receives FDA clearance for K-D Balance™ App

King-Devick technologies, inc., a leading provider of evidence- based assessment tools, today announced it has received 510(k) clearance from the...


Apr 16, 2018, 17:00 ET Zimmer Biomet Announces FDA Clearance and First Surgical Case of the Persona® Trabecular Metal™ Tibia

Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the completion of the first...


Apr 16, 2018, 06:50 ET Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder

Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA)...


Apr 16, 2018, 01:00 ET Roche receives FDA clearance for cobas® CT/NG for cobas® 6800/8800 Systems

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas® CT/NG...


Apr 12, 2018, 07:05 ET FDA Permits Marketing of IDx-DR for Automated Detection of Diabetic Retinopathy in Primary Care

IDx, a privately-held AI diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has granted the company's De Novo...


Apr 12, 2018, 07:00 ET TransMedics, Inc. Receives FDA Pre-Market Approval (PMA) for its OCS™ Lung System for Near-Physiologic Preservation and Assessment of Lungs for Transplantation

TransMedics, Inc., a medical technology company that is transforming the important therapy of solid organ transplantation for patients with...


Apr 11, 2018, 08:35 ET Registrar Corp Launches MyFDA.com, the All-In-One Solution for FDA Regulatory Compliance

Registrar Corp has launched MyFDA.com, a simple online portal that makes it easy for food and beverage businesses to manage their FDA compliance....


Apr 10, 2018, 21:43 ET Tuberous Sclerosis Alliance salutes FDA approval of Afinitor® DISPERZ (everolimus) as the first adjunctive treatment approved in US for patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures

Today, the Tuberous Sclerosis Alliance (TS Alliance) is pleased to share that the U.S. Food and Drug Administration has approved the drug Afinitor,...


Apr 10, 2018, 19:50 ET Novartis drug Afinitor DISPERZ® receives FDA approval to treat TSC-associated partial-onset seizures

Novartis today announced that the US Food and Drug Administration (FDA) has approved Afinitor DISPERZ® (everolimus tablets for oral suspension),...


Apr 09, 2018, 12:13 ET Bayer Statement about Essure® Label Update

Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for the Essure® System for Permanent Birth...


Apr 09, 2018, 08:15 ET Varian Launches Velocity 4.0 Cancer Imaging Software with Selective Internal Radiation Therapy Dosimetry Analysis

Varian (NYSE: VAR) today announced a new version of its Velocity™ cancer imaging software which includes Rapidsphere™, a module for Y90 Selective...


Apr 06, 2018, 07:33 ET Impax Launches a Generic Version of Estrace® Cream (estradiol vaginal cream, USP, 0.01%)

Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has launched a generic version of Estrace® Cream...


Apr 05, 2018, 08:30 ET Sanmina Achieves FDA Registration at Its Facilities in Chennai, India

Sanmina Corporation (Nasdaq: SANM), a leading integrated manufacturing solutions company that makes some of the world's most complex and innovative...