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FDA Approval Headlines from PR Newswire


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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.
EYLEA® (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema (DME)
Cynosure® Announces PicoSure® Is FDA-Cleared To Treat Acne Scars
Diplomat receives distribution contract for Zydelig® (idelalisib)
IMBRUVICA® (ibrutinib) Receives Regular Approval by U.S. FDA in Chronic Lymphocytic Leukemia (CLL) and CLL patients with del 17p
U.S. FDA Grants Regular (Full) Approval for IMBRUVICA® for Two Indications
New Chlamydia and Gonorrhea Assays on the BD Viper™ LT System Receive FDA 510k Clearance
Lorus Therapeutics Receives FDA Clearance of IND to Initiate LOR-253 Clinical Program in Patients with AML, MDS and other Blood Cancers
QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients
AcelRx Pharmaceuticals Receives Complete Response Letter from FDA for New Drug Application for Zalviso™
FDA Approves Flonase® Allergy Relief For Sale Over-The-Counter In The United States
Cynosure Receives Expanded FDA Clearance to Market PicoSure™ for Treatment of Acne Scars
Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system
The Leukemia & Lymphoma Society Applauds FDA's Approval of Idelalisib To Treat Three Types of Blood Cancers
MedNet Appoints Clareece West As Chief Operating Officer

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PR Newswire - United Business Media