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FDA Approval Headlines from PR Newswire


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Cepheid Receives FDA Clearance for Xpert Flu/RSV XC
FDA Grants QIDP Designation to Bayer's Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation
Kubtec® Announces FDA Approval of the Highest Resolution Low Dose Portable Digital Radiography System for NICU
Purdue Pharma L.P. Receives FDA Approval for Hysingla™ ER (hydrocodone bitartrate) Extended-Release Tablets CII, A Once-Daily Opioid Analgesic Formulated with Abuse-Deterrent Properties
AZE Technology, Inc. Announces FDA Approval of Phoenix (Volume Registration Viewer)
Regeneron and Sanofi Announce that Dupilumab Has Received FDA Breakthrough Therapy Designation in Atopic Dermatitis
Great Basin Submits 510(k) Application to FDA for Group B Strep Assay
Argon Medical's CLEANER XT™ and CLEANER 15™ Rotational Thrombectomy Systems Receive FDA Clearance for Mechanical Declotting and Infusion in the Peripheral Vasculature
BerGenBio Receives Orphan-drug Designation from FDA for BGB324 in the Treatment of Acute Myeloid Leukaemia
Valeant Pharmaceuticals And IDEAL IMPLANT Announce FDA And Health Canada Approval To Market Ideal Implant For Cosmetic Breast Augmentation
AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH™
Syneron Candela Expands Capabilities of UltraShape Non-Invasive Fat Destruction Platform, Receives FDA Clearance for the New U-Sculpt Transducer and Enhanced Ultrasound Power
U.S. FDA Approves Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (paliperidone palmitate) for the Treatment of Schizoaffective Disorder
Actavis Announces FDA Acceptance of sNDA for SAPHRIS® (asenapine) for the Treatment of Bipolar I Disorder in Pediatric Patients
Cell Source's Megadose Drug Combination Receives Regulatory Approval in Italy to Commence Human Clinical Trials
Par Pharmaceutical Announces First FDA Approval of Vasostrict™ (vasopressin injection, USP)
West Receives 510(k) Clearance for NovaGuard™ SA Safety System
FDA Accepts Amgen's Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab
Zimmer Announces FDA Clearance of the Stand-alone Optio-C® Anterior Cervical System for use with Structural Allograft/Autograft
ImThera Medical, Inc. Receives FDA Approval for Pivotal Study for Obstructive Sleep Apnea Device
Endo Receives Final Approval for Generic Version of Valcyte®
MCRA Assists Wright Medical Group, Inc. with Obtaining FDA PMA Approvable Decision for Augment® Bone Graft
FDA Issues Complete Response Letter for Aeterna Zentaris' Macrilen™ NDA in Adult Growth Hormone Deficiency
OLYSIO® (simeprevir) Gains Additional FDA Approval as Once-Daily, All-Oral Interferon- and Ribavirin-Free Treatment Option in Combination with Sofosbuvir for Adults with Genotype 1 Chronic Hepatitis C Infection
Hospira Announces U.S. Launch of Generic Paricalcitol Injection
Lilly's CYRAMZA® (ramucirumab) in Combination with Paclitaxel Granted FDA Approval for Advanced Gastric Cancer After Prior Chemotherapy
Ranbaxy Receives Approval From FDA To Market Fenofibrate Capsules USP, 43 mg And 130 mg
Mylan Launches Generic Loestrin 24 Fe®
Changing the Way we Combat Bacterial Infections: Dutch Biotech Micreos Launches First Bacteria-Killing Enzyme for Human Use Against MRSA
Advinus Therapeutics, A TATA Enterprise, Meets Milestone in Drug Discovery Alliance English
Glenmark Generics Receives Final ANDA Approval for Omeprazole DR Capsules
D-Pharm Reports First Results From its Phase 2 Clinical Study of THR-18 In Acute Stroke Patients Treated with tPA
First FDA-Approved, Once Daily Application 5% Minoxidil Formula for Women Hits the Market
Breckenridge Announces Approval of QUETIAPINE FUMARATE TABLETS
Boehringer Ingelheim Announces U.S. Filing Acceptance of New Drug Application for Spiriva® Respimat® (tiotropium bromide) Inhalation Spray for the Treatment of Asthma
Sanofi Pasteur Announces FDA Approval of Updated Prescribing Information for Fluzone® High-Dose Vaccine for Adults 65 and Older
Syneron Candela Announces FDA Clearance of PicoWay Picosecond Laser for Tattoo Removal
BioDelivery Sciences Announces the Availability of BUNAVAIL™ in the U.S.
Veloxis announces tentative approval of Envarsus® XR
Sexual Dysfunction No Longer Inevitable When Treating Enlarged Prostate
U.S. FDA Cardiovascular and Renal Drugs Advisory Committee Makes Recommendation on Daiichi Sankyo's Once-Daily SAVAYSA™ (edoxaban) for the Reduction in Risk of Stroke and Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation
RenovoCath™ RC120 Catheter Receives FDA Clearance
TWi Pharmaceuticals Receives US FDA Approval on Generic Donepezil Hydrochloride Tablets USP, 23 mg, its fifth ANDA from US FDA
Kiadis Pharma's Lead Product ATIR™ Granted Orphan Drug Designation by EMA for the Treatment of Acute Myeloid Leukemia
Flublok® Influenza Vaccine Now Approved for Adults Ages 18 and Older
The National Meningitis Association Applauds FDA Approval of First Serogroup B Meningococcal Disease Vaccine English
InspireMD Investigational Device Exemption (IDE) amendment approved by the FDA
Aethlon Medical Discloses Ebola Treatment Pathways in the United States English
Nephros Receives 510(k) Clearance for DSU-H and SSU-H Ultrafilters
Araim Pharmaceuticals Given FDA Fast Track Designation to ARA 290 for the Treatment of Sarcoidosis-associated Small Fiber Neuropathy

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