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Healthcare News Roundup: FDA

 HSMN NewsFeed - 20 Oct 2021
FDA Expands Approval of Dupixent(R) (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Oct 2021
FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 18 Oct 2021
Oyster Point Pharma Announces FDA Approval of TYRVAYA(TM) (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 13 Oct 2021
Varian Receives FDA "Breakthrough Device Designation" For Embozene(R) Microspheres For Genicular Artery Embolization For Symptomatic Knee Osteoarthritis
Devices Interventional FDA
 HSMN NewsFeed - 13 Oct 2021
FDA Approves Verzenio(R) (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 8 Oct 2021
Alpha Tau Receives FDA's Breakthrough Device Designation for the Treatment of Recurrent GBM
Devices Oncology FDA
 HSMN NewsFeed - 7 Oct 2021
Venclose MAVEN Earns FDA Clearance to Treat Incompetent Perforator Veins
Devices Interventional FDA
 HSMN NewsFeed - 6 Oct 2021
U.S. FDA Accepts COUR Pharmaceuticals Investigational New Drug Application (IND) for a Proof-of-Concept Study for the Treatment of Primary Biliary Cholangitis (PBC)
Biopharmaceuticals FDA
 HSMN NewsFeed - 6 Oct 2021
BD Announces 510(k) Clearance of Expanded Indications for the Rotarex(TM) Atherectomy System
Devices Interventional FDA
 HSMN NewsFeed - 5 Oct 2021
Amber Implants VCFix(R) spinal system receives US FDA Breakthrough designation
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Sep 2021
TransMedics Receives FDA Approval for its OCS Liver System for Preservation and Assessment of Donor Livers for Transplantation
Devices FDA
 HSMN NewsFeed - 23 Sep 2021
MolecuLight i:X(R) Receives FDA 510(k) Clearance for the Device's Ability to Detect Wounds Likely to Contain Pseudomonas aeruginosa (PA)
Devices Wound Care FDA
 HSMN NewsFeed - 22 Sep 2021
Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 21 Sep 2021
FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 19 Sep 2021
Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX(R) (varenicline) Tablets Due to N- Nitroso Varenicline Content
Biopharmaceuticals FDA Product Recall
 HSMN NewsFeed - 10 Sep 2021
CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for the U.S. Clinical Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR(TM) Antithrombotic Removal System During Urgent Cardiothoracic Surgery
Devices Surgery FDA
 HSMN NewsFeed - 8 Sep 2021
Intelivation Technologies received FDA approval for the Advantage-C(TM) PEEK Cervical Interbody Fusion device
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 7 Sep 2021
RenovoRx Receives New 510(k) Clearance for its RenovoCath(R) Delivery System Designed for Targeted Treatment of Solid Tumors
Devices Drug Delivery Oncology FDA
 HSMN NewsFeed - 6 Sep 2021
U.S. FDA Placed a Clinical Hold on BMN 307 Phearless Phase 1/2 Gene Therapy Study in Adults with PKU Based on Interim Pre-clinical Study Findings
Biopharmaceuticals FDA
 HSMN NewsFeed - 1 Sep 2021
Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System(TM)
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 1 Sep 2021
Tyber Medical Receives Largest FDA 510(k) Clearance For Expanded Line Of Anatomical Plating Systems
Devices Orthopaedic FDA
 HSMN NewsFeed - 31 Aug 2021
MicroTransponder(R) Receives FDA Approval for Breakthrough Device Benefiting Stroke Survivors
Devices Neurology FDA
 HSMN NewsFeed - 30 Aug 2021
Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-BCMA-ALLO1, an Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Aug 2021
Visby Medical(TM) Receives FDA Clearance and CLIA Waiver at the Point of Care for PCR Sexual Health Test
Diagnostics FDA
 HSMN NewsFeed - 30 Aug 2021
Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant
Devices Orthopaedic FDA
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