FDA Approval Headlines from PR Newswire

< Go Back

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
Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders
Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance For ProctiGard™
Two UL Battery Safety Standards Are now FDA Recognized Consensus Standards for Medical Devices
Glide Pharma Completes Successful Proof-of-Concept Study with Novel Solid Dose Formulation of Octreotide
Boston Scientific Receives FDA Approval for REBEL™ Platinum Chromium Coronary Stent System
Avanir Pharmaceuticals Announces FDA Acceptance of IND for AVP-786 for the Adjunctive Treatment of Major Depressive Disorder
Maxwell Biotech Venture Fund's Portfolio Company MetaMax Announces Enrollment of First Patients in Phase 1/2a Clinical Trial of its Lead Anticancer Drug MM-D37K
Syneron Receives China CFDA Clearance for elure™ Advanced Skin Brightening Lotion
Regulus Receives Orphan Drug Designation for RG-012, a microRNA Therapeutic for the Treatment of Alport Syndrome
Varian Medical Systems Receives FDA 510(k) Clearance for Calypso® Soft Tissue Beacon® Transponder
Expanding Orthopedics Inc. has obtained FDA Clearance for its FLXfit™, the world's first 3D expandable interbody cage
InterMune Receives FDA Breakthough Therapy Designation For Pirfenidone, An Investigational Treatment For IPF
Bausch + Lomb's VICTUS® Femtosecond Laser Platform Receives 510(k) Clearance from FDA for Lens Fragmentation Procedure
FDA Grants Astellas Qualified Infectious Disease Product Designation for Isavuconazole for the Treatment of Invasive Candidiasis
Boehringer Ingelheim's Investigational Therapy Nintedanib Receives FDA Breakthrough Therapy Designation
IBA Receives FDA Approval of its New Compact Gantry Clearing the Way for Proteus®ONE
FDA Approves the Freedom® Portable Driver That Powers The SynCardia Total Artificial Heart
Purdue Pharma L.P. Receives FDA Approval for 7.5 mcg/hour Dosage Strength of Butrans® (Buprenorphine) Transdermal System CIII
S&M Brands, Inc. Announces FDA Approval On Its Newly Redesigned Riverside® Cigarette Brands
Arrowroot Capital Invests $4 Million In MedNet Solutions
Upsher-Smith Announces Immediate Availability Of A Generic Equivalent To Qudexy™ XR (Topiramate) Extended-Release Capsules
Medac Pharma, Inc. Secures FDA Approval of Rasuvo (methotrexate) injection for Rheumatoid Arthritis, Poly-Articular-Course Juvenile Idiopathic Arthritis and Psoriasis
VENITI™, Inc. Announces FDA Approval of IDE for VENITI VICI™ Venous Stent System
EVZIO™ (naloxone HCl injection) Auto-Injector Now Available in the United States for the Emergency Treatment of Opioid Overdose
Quantel Medical's Optimis Fusion™ Receives FDA 510(k) Clearance Spanish
Par Pharmaceutical Begins Shipment of Fluphenazine Decanoate Injection, USP
Actavis Confirms Generic Ampyra® Patent Challenge
Protein Sciences Receives Approval from FDA for 2014/15 Formulation of Flublok® Influenza Vaccine
Perrigo Announces FDA Final Approval For The Store Brand Equivalent To Advil® Congestion Relief Tablets, 200 mg/10 mg
FDA Grants Priority Review Designation for Purdue Pharma's Once-Daily Hydrocodone Bitartrate Extended-Release Tablets Formulated with Abuse-Deterrent Properties
FDA Approves NovoSeven® RT for the Treatment of Glanzmann's Thrombasthenia (GT) With Refractoriness
Novartis personalized cell therapy CTL019 receives FDA Breakthrough Therapy designation
University of Pennsylvania's Personalized Cellular Therapy for Leukemia Receives FDA's Breakthrough Therapy Designation
CASI Pharmaceuticals Receives U.S. Orphan Drug Designation For The Use Of ENMD-2076 To Treat Hepatocellular Carcinoma
NIFTY™ Becomes First CFDA Approved Non-Invasive Prenatal Genetic Test
BioLight Announces Issuance of U.S. Patent for the Long-Term Controlled-Release Drug-Delivery Insert Platform
Upsher-Smith Announces Launch Of The First And Only Generic Transdermal Testosterone Gel Available In Three Convenient Configurations
U.S. FDA Accepts NDA Filing for Boehringer Ingelheim's Investigational Nintedanib and Grants Priority Review Designation for the Treatment of Idiopathic Pulmonary Fibrosis
Pharma Two B Expands List of Clinical Sites Enrolling for Phase IIb Study of P2B001 for PD to 25
Inova Labs Receives FDA Clearance for Activox DUO2™ - The First Integrated Stationary and Portable Oxygen Concentrator System
ReShape Medical® Submits PMA Application to FDA for Non-Surgical Weight Loss Device
Amgen Receives FDA Breakthrough Therapy Designation For Investigational BiTE® Antibody Blinatumomab In Acute Lymphoblastic Leukemia
Expanding Orthopedics Inc. has Obtained CE Mark for its Unique FLXfit™, 3D Expandable Interbody Cage
Nephros Announces FDA 510(k) Submission of DSU-H and SSU-H Ultrafilters to be used to filter EPA quality drinking water to remove microbiological contaminants and waterborne pathogens

< Prev Next >
PR Newswire - United Business Media