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Healthcare News Roundup: FDA

 HSMN NewsFeed - 1 Dec 2021
Insightec Announces FDA Clearance For Exablate Prostate To Treat Prostate Tissue
Devices Urology FDA
 HSMN NewsFeed - 30 Nov 2021
FDA Authorizes PrecisionOS to Market VR Surgical Planning Tool
Devices Surgery FDA
 HSMN NewsFeed - 29 Nov 2021
Viracta Therapeutics Announces Orphan Drug Designation Granted by FDA for its All-Oral Combination of Nanatinostat and Valganciclovir (Nana-val) for the Treatment of Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Nov 2021
Hyperfine Receives FDA Clearance for Deep Learning Portable MRI, Defining the Future of Life-Saving Diagnostics
Devices Radiology FDA
 HSMN NewsFeed - 19 Nov 2021
BioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Nov 2021
FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed by Datar Cancer Genetics
Diagnostics Oncology FDA
 HSMN NewsFeed - 16 Nov 2021
Sofwave(TM) Announces FDA clearance of New Lifting Indications for Eyebrow, Sub-Mental (beneath the chin) and Neck Facial Areas
Devices Dermatology FDA
 HSMN NewsFeed - 15 Nov 2021
Lunit Gets FDA Nod for AI-based Chest X-ray Triage Solution, Developed for Sorting of Emergency Cases
Devices Radiology FDA
 HSMN NewsFeed - 8 Nov 2021
FDA Grants Profounda Orphan Drug Designation Approval for Treatment of Invasive Candidiasis with Miltefosine
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Nov 2021
Azurity Pharmaceuticals, Inc. Announces FDA Approval of Eprontia(TM) (Topiramate) Oral Solution
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 3 Nov 2021
Insightec Announces FDA Approval of Exablate Neuro for the Treatment of Parkinson's Disease
Devices Neurology FDA
 HSMN NewsFeed - 1 Nov 2021
Theseus Pharmaceuticals Announces FDA Clearance of Investigational New Drug Application for THE-630, a Pan-Variant KIT Inhibitor in Development for the Treatment of Gastrointestinal Stromal Tumors (GIST)
Biopharmaceuticals Oncology 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
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