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The Healthcare Sales & Marketing Network celebrates 27 years serving the medical sales & marketing community.Connecting Medical Independent Sales Reps and Distributors with Manufacturers and New Product LinesConnecting Medical Independent Sales Reps and Distributors with Manufacturers and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 17 Jan 2025
FDA Approves LUMAKRAS(R) (Sotorasib) in Combination with Vectibix(R) (Panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 15 Jan 2025
New Drug Application Initiated with U.S. FDA for TAR-200, the First and Only Intravesical Drug Releasing System for Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 13 Jan 2025
Cresilon Announces U.S. Nationwide Launch of TRAUMAGEL
Devices FDA
 HSMN NewsFeed - 13 Jan 2025
Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma
Diagnostics Oncology FDA
 HSMN NewsFeed - 8 Jan 2025
Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 31 Dec 2024
Kazia Therapeutics Provides Update on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 Dec 2024
Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig(TM) with ENHANZE(R) for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo(R) (nivolumab) Indications
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 13 Dec 2024
Zimmer Biomet Receives FDA Clearance for OsseoFit(TM) Stemless Shoulder System for Total Shoulder Replacement
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Dec 2024
U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
Devices Cardiology FDA
 HSMN NewsFeed - 10 Dec 2024
PENTAX Medical Obtained US FDA 510(k) Clearance for New Models of the PENTAX Medical i20c Video Endoscope Series
Devices Gastroenterology FDA
 HSMN NewsFeed - 4 Dec 2024
Study published in the New England Journal of Medicine AI Concludes that the Sepsis ImmunoScore(TM), the First FDA-Authorized AI Tool for Sepsis, has both significant Diagnostic and Predictive Power
Diagnostics
 HSMN NewsFeed - 27 Nov 2024
PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
Biopharmaceuticals FDA
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