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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 - 4 Apr 2018
Proteostasis Therapeutics Receives FDA Fast Track Designation for Triple Combination Program in Patients with Cystic Fibrosis
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Apr 2018
FDA Approves GORE(R) CARDIOFORM Septal Occluder for PFO Closure to Prevent Recurrent Ischemic Stroke
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 2 Apr 2018
Endo Agrees to Extend Temporary Stay of FDA Litigation
Biopharmaceuticals FDA Litigation
 HSMN NewsFeed - 28 Mar 2018
Haemonetics Announces Regulatory Clearances of NexSys PCS(TM) Enhanced Software with YES(TM) Technology
Devices FDA Regulatory
 HSMN NewsFeed - 28 Mar 2018
Mylan Introduces Symfi(TM) Triple Combo Once-Daily HIV Treatment in the U.S.
Biopharmaceuticals HIV/AIDS FDA Product Launch
 HSMN NewsFeed - 27 Mar 2018
Breckenridge Pharmaceutical, Inc. Announces Final Approval of its ANDA Entecavir tablets (Baraclude(R))
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 27 Mar 2018
FDA Approves New Innovations on Hologic's 3Dimensions(TM) Mammography System, the Fastest, Highest Resolution Breast Tomosynthesis System Ever(1)
Devices Oncology Radiology FDA
 HSMN NewsFeed - 27 Mar 2018
FDA approves Toujeo(R) Max SoloStar(R)
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 27 Mar 2018
Convexity Scientific Receives FDA Clearance For Its FLYP(TM) Nebulizer, Unveils The New Device At Medtrade Spring
Devices FDA Product Launch
 HSMN NewsFeed - 26 Mar 2018
FDA approves inclusion of data from safety outcomes trial in the Tresiba(R) label
Biopharmaceuticals Endocrinology Cardiology FDA
 HSMN NewsFeed - 26 Mar 2018
Bioness Receives FDA Clearance for myBioness(TM) iOS app for mobile control of the L300 Go(TM) System
Devices FDA
 HSMN NewsFeed - 26 Mar 2018
DarioHealth Receives U.S. FDA Clearance for iPhone 7, 8 and iPhone X Smart Glucose Meter
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 26 Mar 2018
Bayer Announces Completion of Rolling Submission of New Drug Application in the U.S. for Larotrectinib for the Treatment of TRK Fusion Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 22 Mar 2018
Respiratory Motion, Inc. is excited to announce FDA clearance for use of the ExSpiron(TM) 1Xi Minute Ventilation Monitor in Pediatric Patients
Devices FDA
 HSMN NewsFeed - 21 Mar 2018
Longhorn Vaccines and Diagnostics LLC receives de novo clearance by the U.S. Food and Drug Administration for PrimeStore(R) Molecular Transport Medium establishing a new class of microbial nucleic acid stabilization devices for molecular testing
Devices Diagnostics FDA
 HSMN NewsFeed - 20 Mar 2018
Therapix Biosciences Announces FDA Clearance of Investigational New Drug (IND) for Phase IIa Clinical Trial of THX-110 in the Treatment of Chronic Low Back Pain
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Mar 2018
Amplyx Pharmaceuticals Receives Fourth "Qualified Infectious Disease Product" (QIDP) Designation from the FDA for APX001
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Mar 2018
Edwards' Acumen Hypotension Prediction Index Launches In The U.S.
Devices Monitoring FDA Product Launch
 HSMN NewsFeed - 16 Mar 2018
Q Biomed Inc. Announces FDA Filing for Approval of a New Manufacturing Facility for Non-Opioid Strontium Chloride SR89 Injection USP for Relief of Cancer Bone Pain
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Mar 2018
FDA Approves Hizentra(R) (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Mar 2018
Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer
Biopharmaceuticals Oncology Urology FDA
 HSMN NewsFeed - 15 Mar 2018
DxNow, Inc. Receives FDA 510(k) Clearance for ZyMōt(TM) ICSI and ZyMōt(TM) Multi Sperm Separation Devices
Devices FDA
 HSMN NewsFeed - 14 Mar 2018
Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for Transforaminal Lumbar Interbody Fusion Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Mar 2018
Exalenz Bioscience’s BreathID(R) Hp & BreathID Hp Lab Systems Receive FDA Clearance for Diagnosis of Helicobacter pylori Testing in Pediatric Patients
Diagnostics FDA
 HSMN NewsFeed - 12 Mar 2018
Medtronic Receives FDA Approval for Guardian Connect Continuous Glucose Monitoring (CGM) System for People Living with Diabetes
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 9 Mar 2018
FDA Approves Pivotal Clinical Trial for Technology to Treat Overactive Bladder
Devices Urology FDA
 HSMN NewsFeed - 8 Mar 2018
Roche launches the new cobas m 511 analyzer, signaling a new era in hematology testing
Diagnostics FDA Product Launch
 HSMN NewsFeed - 7 Mar 2018
Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Mucinex(R) DM Maximum Strength Extended Release Tablets
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 7 Mar 2018
Panther Orthopedics, Inc. Receives FDA 510(k) Clearance for the PUMA System(TM) - An Orthopedic Flexible Fixation Device
Devices Orthopaedic FDA
 HSMN NewsFeed - 6 Mar 2018
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
Diagnostics Oncology FDA
 HSMN NewsFeed - 5 Mar 2018
U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 2 Mar 2018
Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Biopharmaceuticals FDA
 HSMN NewsFeed - 2 Mar 2018
FDA to Review DUPIXENT(R) (dupilumab) as Potential Treatment for Moderate-to-Severe Asthma
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Mar 2018
SUBLOCADE(TM) (Buprenorphine Extended-Release) is Now Available as First and Only Monthly Injectable Buprenorphine in the U.S. to Treat Patients with Moderate to Severe Opioid Use Disorder
Biopharmaceuticals FDA Product Launch
 HSMN NewsFeed - 28 Feb 2018
SnoreRx, Now Available at CVS, is First and Only FDA Certified Non-prescription Anti Snoring Treatment
Devices Product Launch
 HSMN NewsFeed - 23 Feb 2018
Kazia Receives FDA Orphan Designation for GDC-0084
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Feb 2018
Getinge announces U.S. Food and Drug Administration 510(k) clearance for PulsioFlex Monitoring System and PiCCO Module
Devices Monitoring FDA
 HSMN NewsFeed - 23 Feb 2018
Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Feb 2018
Access Vascular Receives FDA Clearance For Its HydroPICC Catheter
Devices FDA
 HSMN NewsFeed - 16 Feb 2018
Photocure Announces U.S. FDA Approval of New Indication for Blue Light Cystoscopy with Cysview(R)
Devices Oncology FDA
 HSMN NewsFeed - 15 Feb 2018
Viz.ai Granted De Novo FDA Clearance for First Artificial Intelligence Triage Software
Devices Radiology Neurology FDA
 HSMN NewsFeed - 15 Feb 2018
Arterys Receives First FDA Clearance for Broad Oncology Imaging Suite with Deep Learning
Devices Radiology Oncology FDA
 HSMN NewsFeed - 14 Feb 2018
Teligent, Inc. Announces FDA Approval of Betamethasone Dipropionate Lotion USP (Augmented), 0.05%
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 13 Feb 2018
Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock
Devices Cardiology FDA
 HSMN NewsFeed - 13 Feb 2018
FDA Approves New HPV Test that Detects and Identifies HPV Genotypes that put Women at High Risk for Cervical Cancer
Diagnostics FDA
 HSMN NewsFeed - 13 Feb 2018
Sandoz announces US FDA approval and launch of Glatopa(R) 40 mg/mL three times-a-week generic option for relapsing forms of multiple sclerosis
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 9 Feb 2018
Salix Provides Update on FDA Submission for PLENVU(R)
Biopharmaceuticals Gastroenterology FDA
 HSMN NewsFeed - 8 Feb 2018
SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Feb 2018
N8 Medical Submits IDE for Breakthrough CeraShield(TM) Endotracheal Tube Device
Devices FDA
 HSMN NewsFeed - 8 Feb 2018
ZYTIGA(R) (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
Biopharmaceuticals Oncology FDA
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