Healthcare Sales & Marketing Network News: FDA

Healthcare News Roundup: FDA

HSMN NewsFeed - 19 Mar 2019
Atreon Orthopedics Received FDA Clearance for Rotator Cuff Regeneration Product
Devices Regenerative Medicine Orthopaedic FDA

HSMN NewsFeed - 18 Mar 2019
Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD
Biopharmaceuticals FDA Regulatory

HSMN NewsFeed - 18 Mar 2019
Allergan Announces FDA Approval of AVYCAZ(R) (ceftazidime and avibactam) for Pediatric Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Mar 2019
Via Surgical Receives FDA Clearance for Its FasTouch(TM) Absorbable Fixation System
Devices Surgery FDA

HSMN NewsFeed - 14 Mar 2019
FDA Approves New Indication for Valve Repair Device to Treat Certain Heart Failure Patients with Mitral Regurgitation
Devices Interventional Cardiology FDA

HSMN NewsFeed - 14 Mar 2019
BD Receives U.S. FDA Approval for First Venous Stent to Treat Iliofemoral Venous Occlusive Disease
Devices Interventional FDA

HSMN NewsFeed - 13 Mar 2019
FDA Grants De Novo for the HemoSonics Quantra(R) QPlus System; This Revolutionary Diagnostic Provides Unique Information for Accessing Coagulation at the Point of Care; Now Commercially Available in US
Devices Diagnostics FDA

HSMN NewsFeed - 11 Mar 2019
Alcyone Lifesciences Receives Breakthrough Device Designation from U.S. FDA for the ThecaFlex DRx(TM) System
Devices Neurology Oncology Drug Delivery FDA

HSMN NewsFeed - 11 Mar 2019
Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Mar 2019
Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Mar 2019
FDA Accepts Supplemental Biologics License Applications (sBLAs) for BOTOX(R) (onabotulinumtoxinA) for Pediatric Patients with Upper and Lower Limb Spasticity
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Mar 2019
Ampio Updates Regulatory Status for Ampion
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Mar 2019
Instrumentation Laboratory Receives US FDA Clearance For New Gem Premier Chemstat(TM) Testing System
Diagnostics FDA

HSMN NewsFeed - 5 Mar 2019
Perrigo Confirms Patent Challenge for Generic Version of Nascobal(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 27 Feb 2019
Breckenridge Announces Final Approval of its ANDA for Exemestane Tablets (Aromasin(R))
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 27 Feb 2019
eNeura, Inc. Receives FDA Clearance for Acute Treatment and Prevention of Migraine in Children 12 Years of Age and Older
Devices Neurology FDA

HSMN NewsFeed - 25 Feb 2019
FDA Approves Taiho Oncology's LONSURF(R) (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Feb 2019
Agfa Receives FDA 510(k) Clearance for DR 800 With Tomosynthesis
Devices Radiology FDA

HSMN NewsFeed - 21 Feb 2019
ViewRay Announces FDA 510(k) Clearance for Advancements in MRI and Functional Imaging Technologies for MRIdian MRI-Guided Radiation Therapy System
Devices Oncology Radiology FDA

HSMN NewsFeed - 20 Feb 2019
HemoCue Announces FDA 510(k) Clearance and U.S. Launch of Its Latest Point-of-Care Hemoglobin Test, the HemoCue(R) Hb 801 System
Diagnostics FDA Product Launch

HSMN NewsFeed - 20 Feb 2019
MagVenture, Inc.: Robotic Aid to Drugfree Depression Treatment Receives FDA Clearance
Devices Neurology FDA

HSMN NewsFeed - 20 Feb 2019
Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service
Devices Endocrinology FDA

HSMN NewsFeed - 19 Feb 2019
AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Feb 2019
NuVasive's Proprietary Magnetic Implant System To Be Used In First-Of-Its-Kind, All-Internal Bone Transport System
Devices Orthopaedic FDA Regulatory

HSMN NewsFeed - 19 Feb 2019
ReWalk Announces 510k FDA Submission for ReStore(TM) Exo-Suit for Stroke Rehabilitation
Devices FDA

HSMN NewsFeed - 14 Feb 2019
Lipocine Inc. Announces FDA Clearance of IND to Commence Phase 2 Study of LPCN 1144 in Biopsy Confirmed NASH Subjects
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Feb 2019
Bausch & Lomb Receives 510(k) Clearance For Use Of The Tangible(R) Hydra-PEG(R) Custom Contact Lens Coating Technology On Several Of Its Boston(R) Gas Permeable Lens Materials And Zenlens(TM) Family Of Scleral Lenses
Devices Ophthalmology FDA

HSMN NewsFeed - 12 Feb 2019
U.S. FDA Approves DARZALEX(R) (daratumumab) Split-Dosing Regimen
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Feb 2019
BioDirection Receives Breakthrough Device Designation from FDA for Tbit(TM) System
Devices Diagnostics Neurology FDA

HSMN NewsFeed - 11 Feb 2019
FDA Grants Orphan Drug Designation to Amplyx Pharmaceuticals for APX001 for Treatment of Cryptococcosis
Biopharmaceuticals FDA

HSMN NewsFeed - 4 Feb 2019
BioLineRx Receives Orphan Drug Designation From the FDA for its Lead Therapeutic Candidate BL-8040 for the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 28 Jan 2019
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Na�ve Patients with Chronic Lymphocytic Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jan 2019
Zimmer Biomet Receives FDA Clearance for ROSA(R) Knee System for Robotically-Assisted Surgeries
Devices Orthopaedic FDA

HSMN NewsFeed - 24 Jan 2019
BD Launches Ergonomic Pen Needle Technology to Help Optimize Injection Technique
Devices Drug Delivery FDA Product Launch

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