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FDA Approval Headlines from PR Newswire


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Translarna Granted Orphan Drug Designation in the U.S. and Europe for the Treatment of Mucopolysaccharidosis I
Bio2 Technologies, Inc. Announces Receipt of FDA 510(k) Clearance for CLM Bioactive Scaffold
Putney Launches Carprofen Chewable Tablets
Portage's Biohaven Receives Response from FDA to its Pre-IND Meeting Request
D-Pharm Achieves Primary End-point in Phase 2 Clinical Study of THR-18 in Acute Stroke Patients Treated With tPA
Elekta Flexitron brachytherapy treatment delivery available in China
Successful FDA Inspection at Hovione
Apotex Announces FDA Has Accepted For Filing its Biosimilar Application for Pegfilgrastim
Veloxis announces that it has filed an action against the Food and Drug Administration, seeking an order requiring FDA to grant final approval to Envarsus® XR
Lilly's CYRAMZA® (ramucirumab) Receives Third FDA Approval
CSL Behring Submits Biologics License Application for FDA Approval of Recombinant Fusion Protein Linking Coagulation Factor IX with Recombinant Albumin (rIX-FP) for Hemophilia B Patients
Novartis gains FDA approval for Signifor® LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
CVRx® Granted Humanitarian Device Exemption Approval from FDA for Barostim neo legacy™ Hypertension Therapy Device
Novartis gains FDA approval for Signifor® LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
HITLAB Completes GCP Audit for FDA Smart Device & App Compliance
Korean Scientists Publish the Latest Results on Colorectal Cancer Screening Using the M2-PK Test in the Renowned Journal 'Gut and Liver'
FDA Clears Olympus' Narrow Band Imaging® (NBI) for Effective Targeting of Bladder Cancer Biopsies and Improved Visualization of Tumor Margins
FDA: Study Demonstrates Potential for Faster Drug Development
INSIGHTEC Secures $59 Million in Equity Financing and Appoints Maurice R. Ferré, M.D., as Executive Chairman of the Board
Sanofi Pasteur Announces FDA Approval of Fluzone® Intradermal Quadrivalent (Influenza Vaccine) for Adults
TWi Biotechnology Receives Approval of Protocol for Its Drug AC-201 Controlled-Release Tablet, Phase II Clinical Trial in Both the United States and Taiwan
MD Anderson officials react to FDA Approval of Gardasil 9 for the prevention of certain cancers
Lakewood-Amedex Submits Investigational New Drug Application for Bisphosphocin™ Nu-3 for the Treatment of Diabetic Foot Infections
Lupin Launches Authorized Genericfor Celebrex® Capsules
Mylan Launches Generic Robaxin® Injection
Mylan Launches First Generic Version of Orapred ODT®
ArmaGen Announces FDA Acceptance of IND Application for AGT-182 for the Treatment of Hunter Syndrome
Nebraska Methodist Hospital Study: Only EQUASHIELD® Prevents Syringe Plunger Contamination
Research points to need for new approaches to treatment of high blood pressure
FDA Clears the Focus Diagnostics Simplexa™ Flu A/B & RSV Direct Test to Include Eight Circulating Influenza Viruses
Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter
Syneron Candela Signs Agreement with American Medical Systems to Supply Holmium Laser for Urology
FDA Approves Amgen's XGEVA® (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy
Anti-Infective Advisory Committee Recommends Approval Of Actavis' Ceftazidime-Avibactam
Jakafi® (ruxolitinib) receives expanded approval for treatment of polycythemia vera; available through Diplomat
New Clearance For Pediatric Device Will Increase Access To Treatment Of Thoracic Insufficiency Syndrome In Children
QIAGEN to Distribute altona Diagnostic's RealStar® Ebolavirus RT-PCR Kit 1.0, Recently Authorized by the FDA for Emergency Use
FDLI Announces the 2014 Distinguished Service and Leadership Award Winners
Mylan receives tentative FDA approval for paediatric formulations of abacavir/lamivudine through innovative collaboration with ViiV Healthcare and Clinton Health Access Initiative
Fiagon Receives FDA Clearance for ENT Extended Instrument Set
Mylan receives tentative FDA approval for pediatric formulations of abacavir/lamivudine through innovative collaboration with ViiV Healthcare and Clinton Health Access Initiative
CorMedix Inc. Files Request with FDA for QIDP Designation for Neutrolin®
The Leukemia & Lymphoma Society Applauds FDA Approval of Blinatumomab To Treat Patients with Acute Lymphoblastic Leukemia
FDA Approves BLINCYTO™ (Blinatumomab) Immunotherapy for the Treatment of Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
Neutrolin Label Expansion Approved in Germany
FDA Approves PulmoFlow's Tobramycin & Nebulizer Combination for Cystic Fibrosis
Shear genius: New ultrasound technology helps clinicians instantly assess body tissue that may be diseased
Oramed Closes $5 Million Investment From Guangxi Wuzhou Pharmaceutical Company
GI View Ltd. Receives FDA 510(k) Clearance for the Aer-O-Scope™ Colonoscope System for Colorectal Cancer Screening
CytRx Receives Written FDA Communication Regarding Partial Clinical Hold for Aldoxorubicin Clinical Trials

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PR Newswire - United Business Media