Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 8 Mar 2017
Celyad obtains FDA approval to initiate the NKR-2 CAR T cells THINK trial in the USA
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Mar 2017
U.S. FDA Approves Serenity Pharmaceutical’s Noctiva(TM) (desmopressin acetate) – the First Drug Approved for the Treatment of Nocturia
Biopharmaceuticals FDA

HSMN NewsFeed - 6 Mar 2017
Nephros Receives FDA 510(k) Clearance of EndoPur(TM) Endotoxin 10" Filter
Devices FDA

HSMN NewsFeed - 6 Mar 2017
Izun Pharmaceuticals Announces Approval of Curasite(TM) Hydrogel Wound Care Product by FDA
Biopharmaceuticals Wound Care FDA

HSMN NewsFeed - 2 Mar 2017
EnGeneIC Receives FDA Orphan Drug Designation for Targeted EDV(TM) Nanocells to Treat Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 2 Mar 2017
ALK Announces FDA Approval for its House Dust Mite Sublingual Allergy Immunotherapy Tablet (ACARIZAX(R) in Europe)
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Mar 2017
Perrigo Announces FDA Final Approval For The Generic Version Of Axiron(R) Topical Solution, 30 mg/1.5 mL
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 1 Mar 2017
Sangamo Therapeutics Receives Orphan Drug Designation from the FDA for SB-913 Genome Editing Treatment for MPS II
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Mar 2017
CeloNova Biosciences Receives FDA Approval of COBRA PzF(TM) Stent System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 28 Feb 2017
IRIDEX Launches New FDA-Cleared Probe At The Annual American Glaucoma Society Meeting
Devices Ophthalmology Product Launch

HSMN NewsFeed - 28 Feb 2017
aTyr Pharma Receives U.S. FDA Orphan Drug Designation for the Treatment of Limb Girdle Muscular Dystrophy with Resolaris(TM)
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Feb 2017
Velano Vascular Receives Third FDA 510(k) Clearance for Innovative PIVO Needle-Free Blood Draw Technology
Devices FDA

HSMN NewsFeed - 24 Feb 2017
Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage(R) XR
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 24 Feb 2017
Accelerate Diagnostics Receives FDA Marketing Authorization for the Accelerate Pheno(TM) System and Accelerate PhenoTest(TM) BC Kit
Diagnostics FDA

HSMN NewsFeed - 23 Feb 2017
First-Ever Device for Fast and Virtually Painless Blood Draw Receives FDA Clearance
Devices FDA

HSMN NewsFeed - 22 Feb 2017
BD Veritor(TM) System Meets FDA's New Performance Requirements for Rapid Influenza Antigen Detection Tests
Diagnostics FDA

HSMN NewsFeed - 17 Feb 2017
Perrigo Announces FDA Final Approval For Hydrocodone Bitartrate And Homatropine Methylbromide Oral Solution
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 16 Feb 2017
FDA Expands Approval of SPIRIVA(R) RESPIMAT(R) (tiotropium bromide) Inhalation Spray for Maintenance Treatment of Asthma in Children
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Feb 2017
Valeant Receives FDA Approval Of SILIQ(TM) (Brodalumab) For Moderate-To-Severe Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 16 Feb 2017
FDA Grants PMA Approval for Hologic's Aptima(R) Hepatitis C Quant Dx Assay
Diagnostics FDA

HSMN NewsFeed - 15 Feb 2017
Cepheid Announces FDA Clearance Of Xpert(R) Xpress Flu And Xpert Xpress Flu/RSV
Diagnostics FDA

HSMN NewsFeed - 10 Feb 2017
FDA Approves EMFLAZA(TM) (deflazacort) Tablets and Oral Suspension for the Treatment of Duchenne Muscular Dystrophy in Patients 5 Years and Older
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Feb 2017
Access Scientific Announces FDA Clearance for New 3 French, 6 cm POWERWAND to Eliminate Repetitive Needlesticks for IV Access
Devices FDA

HSMN NewsFeed - 8 Feb 2017
FDA Approves Amgen's Parsabiv(TM) (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis
Biopharmaceuticals Endocrinology FDA

HSMN NewsFeed - 7 Feb 2017
Bioness Receives FDA Clearance for the L300 Go(TM) System
Devices Orthopaedic FDA

HSMN NewsFeed - 6 Feb 2017
First U.S. Multi-center Investigational Clinical Trial of 177 Lu PSMA-617 Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer Receives FDA Clearance
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 Feb 2017
Intellipharmaceutics Announces FDA Acceptance for Filing of NDA for Rexista(TM) (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Feb 2017
Zimmer Biomet Announces FDA Approval of Expanded 26-week Efficacy Claim for Gel-One(R) Cross-Linked Hyaluronate for Treatment of Pain Associated with Knee Osteoarthritis
Devices Orthopaedic FDA

HSMN NewsFeed - 30 Jan 2017
FDA Approves First Balloon Expandable Stent Graft for Use in the Iliac Artery
Devices Interventional FDA

HSMN NewsFeed - 26 Jan 2017
Gramercy Extremity Orthopedics Receives FDA 510(k) Clearance for GEO(TM) Bone Screw System
Devices Orthopaedic FDA

HSMN NewsFeed - 24 Jan 2017
Perrigo Announces FDA Approval Of Its First-To-File AB Rated Generic Version Of Topicort(R) Spray, 0.25%
Biopharmaceuticals Generics Dermatology FDA

HSMN NewsFeed - 24 Jan 2017
FDA Grants Priority Review for Genentech’s Actemra(R) (Tocilizumab) Supplemental Biologics License Application for Giant Cell Arteritis, a Form of Vasculitis
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Jan 2017
Camber Spine Technologies Announces 510(k) Clearance For Their Siconus(TM) SI Joint Fixation System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 23 Jan 2017
PleurX(TM) Catheter System Receives FDA 510(k) Clearance for Specific Non-Malignant Recurrent Pleural Effusions
Devices FDA

HSMN NewsFeed - 20 Jan 2017
Synergy Pharmaceuticals’ TRULANCE(TM) (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 20 Jan 2017
Bristol-Myers Squibb Provides Regulatory Update in First-line Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jan 2017
U.S. FDA Approves IMBRUVICA(R) (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Jan 2017
Ezra Announces FDA Acceptance Of Filing Of New Drug Application For EZR-104 For The Treatment Of Hypertension And Heart Failure
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 17 Jan 2017
MindChild Medical, Inc. Announces Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration (FDA) for the MERIDIAN(TM) M110 Fetal Monitoring System
Devices Monitoring FDA

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