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 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...


Jan 06, 2017, 14:45 ET Breckenridge Pharmaceutical, Inc. Announces Final ANDA Approval for Bendamustine HCl Powder for IV (Treanda®)

Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA bendamustine hydrochloride powder for IV (infusion), 25...


Jan 06, 2017, 08:00 ET RG7916 Granted Orphan Drug Designation in the U.S. for the Treatment of Spinal Muscular Atrophy

PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to...


Jan 05, 2017, 11:00 ET ivWatch Receives FDA 510 (K) Clearance to Significantly Advance the Safety of IV Therapy for Pediatric Patients

Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age...


Jan 05, 2017, 09:30 ET Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer

Keystone Nano, Inc., a biopharmaceutical company focused on improving cancer treatments through the application of nanotechnology, announced today...


Jan 05, 2017, 08:30 ET XTL Biopharmaceuticals' Preclinical Studies of hCDR1 Demonstrate Therapeutic Potental In the Treatment of Sjögren's Syndrome

XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing...


Jan 05, 2017, 08:00 ET Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For SB-525 Gene Therapy Program For Hemophilia A

Sangamo BioSciences, Inc. (NASDAQ: SGMO) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational...


Jan 05, 2017, 08:00 ET Neurelis Announces Finalization Of Series B Financing

Neurelis, Inc. today announced that it has finalized a Series B financing round led by HBM Healthcare Investments. In addition, LYZZ Capital, which...


Jan 04, 2017, 16:05 ET Vermillion and ASPiRA LABS Announce Receipt of Formal FDA Clarification Regarding Ovarian Cancer Screening Alert

Vermillion (NASDAQ: VRML) and ASPiRA LABS, a Vermillion company, today announced the receipt of an FDA Clarification Letter regarding OVA1 (MIA)...


Jan 04, 2017, 10:07 ET NeuroRx announces FDA IND clearance for NRX-101 phase 2b/3 study and publication of promising biomarker data

Biotech Showcase at the JP Morgan Healthcare Conference NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute...


Jan 04, 2017, 09:39 ET Roche launches cobas® c 513 analyzer and HbA1c Gen. 3 assay to meet increasing demand for testing of people with diabetes

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and...


Jan 04, 2017, 09:00 ET Senhwa Biosciences CX-4945 Granted Orphan Drug Designation by the US FDA in Cholangiocarcinoma

Senhwa Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CX-4945 for the...