FDA
Apr 04, 2024
C2Dx’s Shaw Scalpel System; Texas Original’s RSO Gummies; Abbott’s Whole Blood Rapid Test FDA Clearance; Medtronic’s TAVR Device FDA Clearance; Nexalin’s Device Improved Symptoms; CYduct Diagnostics’ Positive Study Results
C2Dx Launched Next Generation Shaw Scalpel System On March 26, 2024, C2Dx, a privately-owned medical device company, announced the launch of its Next Generation Shaw Scalpel System. The Shaw Scalpel System has obtained 510(k) clearance from the FDA for the upgraded controller of its advanced surgical techn...
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Apr 02, 2024
AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval
Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH Voydeya (danicopan) has received approval in the United States for use alongside ravulizumab or eculizumab in treating extravascular hemolysis (EVH) in adults dia...
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Mar 28, 2024
TELA Bio Launched Hernia Mesh Fixation Devices; Stryker Acquisition of SERF SAS; FDA 510(k) Clearance for RedDrop Dx’s Blood Collection Device; FDA 510(k) Clearance for Next Generation Shaw Scalpel; LivaNova’s Sleep Apnoea Device Trial; Nanodropper’s Positive Impact on Glaucoma Treatment
TELA Bio Launched FDA-approved Hernia Mesh Fixation Devices On March 21, 2024, TELA Bio, Inc., a medical technology firm, launched its FDA-approved LIQUIFIX devices for hernia repairs in the United States. The LIQUIFIX FIX8™ and LIQUIFIX Precision™ are specifically engineered for laparoscopic and open femo...
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Mar 26, 2024
Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition
Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...
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Mar 21, 2024
Vygon Launched Nutrisafe2 System; Butterfly Network Launched Third-Gen Ultrasound; Cosm Medical Won FDA Clearance; FDA Cleared Sequel Med Tech Automated Insulin Delivery System; IceCure Medical Reported Positive Topline Results; Cerus Announced Positive Results in Blood Purification Trial
Vygon Launched Neonatal Safety in India with Groundbreaking Nutrisafe2 System On March 15, 2024, Vygon, a leader in the production and marketing of specialized medical equipment, introduced Nutrisafe2, a technological leap forward. This state-of-the-art enteral feeding device for neonates guarantees the sa...
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Mar 14, 2024
Allumiqs and Prolytix’s Partnership; Setpoint Medical’s Neuroimmune Modulation Platform gets FDA Breakthrough Designation; MangoRx Launches ‘PRIME’ with FDA-approved TRT; SeaStar Medical Updates Quelimmune Commercial Launch; Ventris Medical Gains 510(k) for Amplify® Bone Graft Putty
MangoRx Officially Launches ‘PRIME’ by MangoRx, Powered by Kyzatrex®️ FDA Approved Oral Testosterone Replacement Therapy (TRT) Treatment On March 12, 2024, Mangoceuticals, Inc. unveiled a groundbreaking development eagerly awaited by many: the launch of 'PRIME' by MangoRx, Powered by Kyzatrex®️. This release mar...
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Mar 12, 2024
BeiGene’s BRUKINSA Gets FDA Accelerated Approval; GSK’s Positive Results in DREAMM-8 Phase III; Sandoz’s Denosumab Biosimilars FDA Approved; Terns Pharma’s TERN-701 Receives Orphan Drug Designation; Wegovy® Approved in US for Overweight Cardiovascular Risk; Travere Therapeutics Submits sNDA for FILSPARI IgAN Full Approval
BeiGene Receives FDA Accelerated Approval for BRUKINSA in Relapsed/Refractory Follicular Lymphoma BeiGene, Ltd., has declared that the FDA has provided accelerated approval for BRUKINSA® (zanubrutinib) to be used in treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), when used alo...
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Mar 07, 2024
Philips Teamed with SyntheticMR; BioPhotas’s Celluma Light Therapy; Boston Scientific’s AGENTTM Drug-Coated Balloon; Varian’s TrueBeam and Edge Radiotherapy Systems; Carthera’s Brain-Blood Barrier Trial; Prototype Device Effectively Treated Multiorgan Failure
Philips Teamed with SyntheticMR to Deliver Breakthrough AI-based Quantitative Brain Imaging in MR to Advance Neurology Care For Patients On March 01, 2024, Philips in collaboration with SyntheticMR announced the launch of Smart Quant Neuro 3D, a significant advancement in objective decision support for diag...
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Mar 05, 2024
Bayer’s New Cardiology Drug Acoramidis; Two Datopotamab Deruxtecan Applications Validated in the EU; AbbVie and OSE Immunotherapeutics Announce Announces Partnership; vTv Therapeutics Makes Major Move With Cadisegliatin; A2 Bio Scores FDA Orphan Drug Designation for its Therapy, A2B530; FDA Fast Track Designation for AlloNK® in Lupus Nephritis
Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...
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Feb 29, 2024
Profound Medical and Siemens Entered Into a Collaboration; CardiAI and Carleton University Forged an Innovative Partnership; BrainMD Launched Revolutionary Smart Collagen Supplements; FDA Approved Seastar’s Quelimmune Device; Nebraska-developed Surgical Robot Received FDA Approval; Catheter Precision Presentated First Clinical Data on LockeT
Profound Medical and Siemens Healthineers Entered Into a Collaboration on Ultrasound Ablation On February 27, 2024, Profound Medical entered into a non-exclusive agreement with Siemens Healthineers. The objective of the agreement was to establish the foundation for Profound's commencement of marketing a comprehe...
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