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

Jan 17, 2017, 09:00 ET CyMedica Orthopedics® announces FDA clearance for e-vive™, the first app-driven muscle activation therapy and patient engagement solution for pre and post-operative knee surgery rehabilitation

CyMedica Orthopedics®, developer and manufacturer of innovative muscle rehabilitation systems announced that it received U.S. Food and Drug...


Jan 17, 2017, 07:15 ET OWC Pharmaceutical Research Corp Issues Annual Letter to Shareholders

OWC Pharmaceutical Research Corp. (OTCQB: OWCP), ("OWCP" or the "Company"), through its Israeli based fully owned subsidiary (One world Cannabis...


Jan 17, 2017, 07:00 ET BioLineRx Announces Initiation of Immuno-Oncology Phase 2 Study to Investigate Combination of BL-8040 and KEYTRUDA® for Pancreatic Cancer

BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing...


Jan 17, 2017, 07:00 ET Check-Cap Enrolls First Patient in Clinical Trial to Support CE Mark of Its C-Scan® Colorectal Cancer Screening System

Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical stage medical diagnostics company developing a capsule-based...


Jan 13, 2017, 20:15 ET Delaware Surgeon Performs Innovative Non-Surgical Weight Loss Procedure

Dr. Isaias Irgau, from Christiana Institute of Advanced Surgery, is the first medical doctor to perform the newly FDA Approved Non-Surgical Weight...


Jan 13, 2017, 16:51 ET U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment

Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has...


Jan 11, 2017, 08:00 ET U.S. FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Trastuzumab

Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has...


Jan 11, 2017, 07:17 ET Paragon CRT® Contact Lenses Approved by China Food & Drug Administration

Paragon Vision Sciences, a world leader in orthokeratology, today announced China Food and Drug Administration (CFDA) approval and commercial...


Jan 11, 2017, 03:00 ET SonaCare Medical Granted FDA Regulatory Clearance for Updated HIFU Prostate Tissue Ablation Device

SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory...


Jan 10, 2017, 11:05 ET Certent Administers Sophisticated Equity Plan for NerdWallet

Certent, Inc., a leading provider of software-as-a-service (SaaS) solutions for equity compensation and financial disclosure management, announces...


Jan 10, 2017, 09:00 ET ViraCyte Granted U.S. FDA Fast Track Designation for Viralym-C

ViraCyte, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viralym-C, ViraCyte's T cell...


Jan 09, 2017, 14:51 ET Egalet Receives FDA Approval for ARYMO™ ER (morphine sulfate) C-II, an Extended-Release Morphine Product Formulated with Abuse-Deterrent Properties for Treatment of Chronic Pain

Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and...


Jan 09, 2017, 12:51 ET Arterys Receives FDA Clearance For The First Zero-Footprint Medical Imaging Analytics Cloud Software With Deep Learning For Cardiac MRI

Arterys, a pioneer in cloud-based medical imaging software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...


Jan 09, 2017, 10:00 ET Debiopharm Group's Triptorelin 6-month Formulation Receives Approval for the Treatment of Central Precocious Puberty (CPP) in Europe

Debiopharm International SA (Debiopharm - http://www.debiopharm.com), a Swiss-based company, part of Debiopharm Group™, today announced that...


Jan 09, 2017, 10:00 ET QIAGEN Submits QuantiFERON®-TB Gold Plus for U.S. Regulatory Approval

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the submission of QuantiFERON®-TB Gold Plus (QFT®-Plus), the fourth...


Jan 09, 2017, 10:00 ET La formulation 6 mois de la triptoréline de Debiopharm Group a reçu l'autorisation pour le traitement de la puberté précoce centrale (PPC) en Europe

Cette formulation à libération prolongée est le premier traitement d'une durée d'action de 6 mois homologué dans l'UE pour la PPC Debiopharm...


Jan 09, 2017, 09:02 ET Arthritis Foundation to Host Osteoarthritis Patient-Focused Drug Development Meeting

The Arthritis Foundation today announced they are hosting an Osteoarthritis (OA) Patient-Focused Drug Development (PFDD) meeting in the Washington,...


Jan 09, 2017, 09:00 ET Vermillion Announces Reimbursement Code Updates for Overa and OVA1

Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company, today announced that the company and its wholly owned subsidiary,...


Jan 09, 2017, 09:00 ET FDA Clears World's Smallest CPAP, ResMed AirMini™

ResMed (NYSE:RMD) announced today at the 35th annual J.P. Morgan Healthcare Conference that the U.S. Food and Drug Administration has cleared...