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FDA Approval Headlines from PR Newswire


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New indication for VIMPAT® (lacosamide): UCB's anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures
InnoPharma Announces FDA Approval of Decitabine for Injection, a Generic Version of DACOGEN®
Nonin Medical Announces FDA Clearance of Nonin Model 3231 USB Pulse Oximeter
Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA
TWi Pharmaceuticals Receives US FDA Final Approval on Generic Megestrol Acetate 125mg/ml Oral Suspension
USC Eye Institute ophthalmologists implant first FDA-approved Argus II retinal prosthesis in western United States
FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure
Asterias Biotherapeutics Receives U.S. FDA Clearance to Initiate Phase 1/2a Clinical Trial of AST-OPC1 in Patients with Cervical Complete Spinal Cord Injury
GSK receives FDA approval of an additional Promacta® (eltrombopag) indication for use in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST)
FDNA Partners with London Medical Databases (LMD) to Provide Long-Awaited Online Access to Leading Dysmorphology Database English
Multimedia assets now available: ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection
Iroko Pharmaceuticals Gains FDA Approval of ZORVOLEX® for Management of Osteoarthritis Pain
ViiV Healthcare receives FDA approval for Triumeq® (abacavir, dolutegravir and lamivudine), a new single-pill regimen for the treatment of HIV-1 infection
Arthrosurface® Receives FDA Clearance for the KISSloc Hallux Valgus Correction System
Mylan Launches First Generic Klor-Con® Extended-Release Tablets
AliveCor Receives First FDA Clearance to Detect a Serious Heart Condition in an ECG on a Mobile Device
Novocure Announces the Submission of a Pre-Marketing Approval Application in Japan for the NovoTTF™-100A System to Treat Recurrent Glioblastoma Spanish
Philips receives FDA 510(k) Clearance for TAVI Precision Treatment Planning Application
GSK receives FDA approval for Arnuity™ Ellipta® (fluticasone furoate) in the US for the treatment of asthma
Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China domestic mark
Mylan Launches Generic Precedex™ Injection - Another Key Product Approval
Westmed, Inc. Receives FDA Clearance for the Vibralung® Acoustical Percussor
ViaCyte, Inc. Announces FDA Acceptance of IND to Commence Clinical Trial of VC-01™ Candidate Cell Replacement Therapy for Type 1 Diabetes
Oramed Granted Patent in Spain for Oral Administration of Insulin
Gamida Cell Announces Investment and Option Agreement with Major Pharmaceutical Company
FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™ (insulin glargine injection)
FDA Accepts CorMedix, Inc. Pivotal Phase 3 Study Protocol
FDA Advisory Committee Recommends Approval of Tiotropium Respimat® for the Maintenance Treatment of COPD
Syneron Medical Introduces New FDA-Cleared 5mm Spot Size for Treatment of Onychomycosis
TMJ Health LLC™ Announces New FDA Cleared Treatment for TMJD, Temporomandibular Joint Disorders
B. Braun Receives FDA Approval for Nutrilipid® 20% English
Equashield Expands Global Footprint With New Canadian Distributor
FDA Grants Orphan Drug Designation for OncoSynergy's Investigational Monoclonal Antibody OS2966 in the Treatment of Glioblastoma
Mirati Therapeutics Receives Orphan Designation from U.S. Food & Drug Administration for Mocetinostat in Diffuse Large B-Cell Lymphoma
Concordia Healthcare Corp. announces first patients enrolled in Phase 2 clinical trial using Photodynamic Therapy with PHOTOFRIN(R) for patients with mesothelioma English
Phosphagenics Completes First IND Enabling Study for TPM(R) / Oxymorphone Patch
U.S. FDA Approves INVOKAMET™ (canagliflozin/metformin HCl) for the Treatment of Adults with Type 2 Diabetes
Pipe Tobacco Council Submits Official Industry Comments on Food and Drug Administration Proposal to Regulate Pipe Tobacco
BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2014 Financials
NextSource Biotechnology Gains FDA Approval for Use of Tradename Gleostine™ (Lomustine), an Anti-Cancer Chemotherapy Agent
FDA Approves the SynCardia Total Artificial Heart With SynHall Valves
AB103 Granted Orphan Medicinal Product Designation in the European Union for the Treatment of Necrotizing Soft Tissue Infections (NSTI)
Genoa Pharmaceuticals Receives Orphan-Drug Designation for Pirfenidone in the Inhaled Treatment of Idiopathic Pulmonary Fibrosis (IPF)
ElMindA Announces FDA Clearance of BNA™ Analysis System
NeuroDerm Announces Eligibility for European Union Centralized Procedure for ND0612H, a Novel Treatment for Advanced Parkinson's Disease
FDA approves Jardiance® (empagliflozin) tablets for adults with type 2 diabetes
FDA Approves Boehringer Ingelheim's Striverdi® Respimat® (olodaterol) Inhalation Spray for Maintenance Treatment of COPD
Isis Pharmaceuticals Initiates Phase 3 Study of ISIS-SMN Rx in Infants with Spinal Muscular Atrophy
Successful FDA Inspection at Hovione's API Manufacturing Plant in Cork, Ireland
Ampio Pharmaceuticals announces the FDA has issued a written response and accepted the Ampio plan for beginning production of Ampion™ in the new facility.

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