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FDA Approval Headlines from PR Newswire


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/K I L L K I L L K I L L - Axiom Worldwide, Inc./
Andrew Technologies Receives FDA 510 (k) Clearance for Autologous Fat Transfer with HydraSolve™ Lipoplasty System - First Liposuction Device with this Clearance.
InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
FDA Approves Second Drug in BD Simplist™ Prefilled Injectable Line of Products
Fuisz Pharma Announces Intent to Divest Strategic Patent for Detection of Opioid Abuse; Seeks Offers for Patent through May 2013
Bausch + Lomb Signs Exclusive License Agreement with Paragon BioTeck for Phenylephrine
MedShape Announces FDA Clearance of New Soft Tissue Anchor for Fast Implantation in Tenodesis, Tendon Transfer Procedures
Neura Therapeutik Addresses FDA Concerns about Abuse, Misuse of Drugs with Development of Safe and Affordable Abuse-Deterrent Opioids
Abbott Announces FDA Approval and U.S. Launch of the TECNIS® Toric Intraocular Lens for Cataract Patients
FDA Advisory Committee recommends approval of BREO™ ELLIPTA™ for the treatment of COPD
Novel Cancer Immunotherapy set to enter Clinical Trials
VIVUS Announces FDA Approval of Qsymia REMS Modification Allowing Access Through Certified Retail Pharmacies
InspireMD Closes $25 Million Underwritten Public Offering
Pittsburgh-Based Rinovum® Women's Health Readies for Market
Oramed Pharmaceuticals Appoints New Chief Operating Officer and VP of Business Development
FDA Approves FibroScan® for Non-invasive Liver Diagnosis
YES Pharma Announces $2.5 Million Investment in Stereokem for 33% Ownership
Tria Beauty, Inc. and Ulta Announce New Retail Partnership
ORTHOWORLD(R) Announces FDA Official to Serve as Panelist at Orthopaedic Manufacturing & Technology Exposition and Conference (OMTEC(R))
Boston Scientific Launches Precision Spectra™ Spinal Cord Stimulator System In The United States
Hawaii Vision Clinic Introduces ChromaGen Life-Changing Lens Technology
Elekta Receives U.S. FDA 510(k) Clearance Following Launch of New Versa HD Radiation Therapy System for Cancer Treatment
MAQUET Cardiovascular Receives FDA 510(k) Clearance And CE Mark Approval For AIR-BAND™ Radial Compression Device
BD Announces FDA 510(k) Clearance and Commercial Launch of BD UltraSafe PLUS™ Passive Needle Guard
Oramed Submits New IND Application for Oral Insulin Trial in the US
InspireMD Announces Pricing of Underwritten Public Offering of Common Stock and Listing on NYSE MKT
Olympus Introduces the World's Only Articulating HD 3D Laparoscopic Surgical Video System
New Molecular Assay Provides Healthcare Facilities with a Simple, Efficient Way to Detect Dangerous Superbug
FDA Approves Duchesnay USA's Diclegis® for Treatment of Nausea and Vomiting of Pregnancy (NVP)
Bausch + Lomb Receives FDA Approval for PROLENSA™ (bromfenac ophthalmic solution) 0.07%
Ibrutinib Receives Third Oncology Breakthrough Therapy Designation from U.S. Food and Drug Administration
Emergency Contraception to Be Available on Store Shelves
Hadasit Bio-Holdings Flagship Portfolio Company Enlivex Awarded Orphan Drug Status for ApoCell Treatment by the FDA
CryoLife Receives FDA Clearance For Next Generation HeRO Device
Mylan Launches First Generic Version of Zovirax® Ointment
FDA Approves Tris Pharma's New Drug Application for Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension
Statement from GlaxoSmithKline Consumer Healthcare on FDA Report Regarding FDA's Changes to the Labeling of Over-the-Counter Nicotine Medications
U.S. FDA Approves INVOKANA™ (Canagliflozin) for the Treatment of Adults with Type 2 Diabetes
Third FDA Clearance for Revolutionary Simbionix Product
Third FDA Clearance for Revolutionary Simbionix Product
New Abbott Test Can Help Doctors Detect the Presence of Two Important Health Issues
BD Enters Pharmaceutical Industry with New Line of Generic Prefilled Injectable Products
FDA Approves ACIPHEX® Sprinkle™ (Rabeprazole Sodium) For Use in Children Ages 1 to 11
MedNet Solutions To Participate In Multiple Clinical Research Conferences In April 2013
Breckenridge announces agreement with Aptalis Pharmatech to market Propranolol Hydrochloride Extended-Release Capsules
Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment
Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
United Therapeutics Announces Receipt Of Second Complete Response Letter For Oral Treprostinil NDA
FDA approves Novartis TOBI® Podhaler™ for certain cystic fibrosis patients, the first and only dry powder inhaled antibacterial in US
FDA Approves Dotarem® (gadoterate meglumine), first macrocyclic and ionic gadolinium-based contrast agent in USA

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PR Newswire - United Business Media