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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 29 Jul 2016
Micro Interventional Devices, Inc. Receives FDA Market Clearance for Permaseal(TM)
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 28 Jul 2016
FDA Clears Expanded Indication for Itamar Medical's WatchPAT(TM) Sleep Apnea Diagnostic Device for Adolescents
Devices Diagnostics FDA
 HSMN NewsFeed - 28 Jul 2016
Caladrius Biosciences Receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 26 Jul 2016
AbbVie Receives U.S. FDA Approval of Once-Daily VIEKIRA XR(TM) (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jul 2016
Amgen and UCB Submit Biologics License Application for Romosozumab to the FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jul 2016
Relievant Medsystems, Inc. Receives FDA 510(k) Clearance for INTRACEPT(R) for the Relief of Chronic Low Back Pain
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 21 Jul 2016
Vasorum Ltd. Receives FDA Approval for Celt ACD(R) Vascular Closure Device
Devices Interventional FDA
 HSMN NewsFeed - 20 Jul 2016
Mylan Launches Generic Crestor(R) Tablets
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 20 Jul 2016
Viracor-IBT Laboratories, Inc.'s Zika Virus RT-PCR Test Receives Emergency Use Authorization From the FDA
Diagnostics FDA
 HSMN NewsFeed - 15 Jul 2016
Medifirst Solutions Is Granted 510(k) FDA Clearance
Devices Dermatology FDA
 HSMN NewsFeed - 13 Jul 2016
SinuSys(TM) Corp. Receives FDA Clearance for the Vent-Os(R) Sinus Dilation Family of Devices
Devices FDA
 HSMN NewsFeed - 12 Jul 2016
HEPATIQ Receives Additional FDA Clearance
Diagnostics FDA
 HSMN NewsFeed - 12 Jul 2016
FDA Approves Shire’s Xiidra(TM) (lifitegrast ophthalmic solution) 5% – The Only Treatment Indicated for the Signs and Symptoms of Dry Eye Disease
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 12 Jul 2016
Alere to Initiate Voluntary Withdrawal of the Alere INRatio(R) and INRatio(R)2 PT/INR Monitoring System
Devices Monitoring FDA Product Recall
 HSMN NewsFeed - 8 Jul 2016
Teligent, Inc. Receives Two FDA Approvals for Topical Prescription Portfolio
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 8 Jul 2016
Essential Medical Inc. Announces FDA Approval to Begin a U.S. Clinical Trial for the MANTA(TM) Large Bore Vascular Closure Device
Devices Interventional FDA
 HSMN NewsFeed - 6 Jul 2016
FDA Grants Merrimack Fast Track Designation for Seribantumab (MM-121) in Non-small Cell Lung Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jul 2016
US FDA pathway opens to SCENESSE(R) following Fast Track designation for treatment of EPP
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Jul 2016
Mylan Launches Generic Fenoglide(R) Tablets
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 5 Jul 2016
Insys Therapeutics Announces FDA Approval of Syndros(TM)
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Jun 2016
Biostage Files for FDA Orphan Drug Designation for Cellspan(TM) Esophageal Implant
Regenerative Medicine FDA
 HSMN NewsFeed - 29 Jun 2016
AbbVie Announces Fourth Breakthrough Therapy Designation Granted by the U.S. Food and Drug Administration (FDA) for Ibrutinib (IMBRUVICA(R)) for Chronic Graft-Versus-Host-Disease (cGVHD), a Rare Condition with Limited Treatment Options
Biopharmaceuticals
 HSMN NewsFeed - 29 Jun 2016
FDA Advisory Committee recommends approval of Jardiance(R) (empagliflozin) for cardiovascular indication in 12-11 vote
Biopharmaceuticals Endocrinology Cardiology FDA
 HSMN NewsFeed - 28 Jun 2016
FDA Grants Priority Review for Genentech’s OCREVUS(TM) (ocrelizumab) Biologics License Application
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 27 Jun 2016
Accuray Receives 510(k) FDA Clearance for the Radixact(TM) Image-Guided Radiation Therapy Platform and Integrated Software
Devices Oncology FDA
 HSMN NewsFeed - 23 Jun 2016
Allergan Announces FDA Approval of Supplemental New Drug Application (sNDA) for AVYCAZ(R) (ceftazidime and avibactam)
Biopharmaceuticals FDA
 HSMN NewsFeed - 21 Jun 2016
Perrigo Announces FDA Clearance And Launch Of Non-GMO* Infant Formulas For The U.S. Store Brand Market
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 20 Jun 2016
Sangamo BioSciences Announces FDA Clearance of Investigational New Drug Application for ZFN-Mediated Genome Editing Treatment of MPS II
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Jun 2016
Lannett Receives FDA Approval For Neomycin Sulfate Tablets USP, 500 mg
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 6 Jun 2016
Allergan Announces FDA Approval of BYVALSON(TM) (nebivolol and valsartan)
Biopharmaceuticals Cardiology FDA
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