news
Sep 28, 2023
Orthofix Launched the Galaxy Fixation Gemini System; Oxford Biodynamics Launched the EpiSwitch Prostate Screening Blood Test; CE Mark for the Medtronic’s New Simplera CGM; FDA 510(k) Clearance to MicroVention’s SOFIA™ EX 5F 115cm; SHL Telemedicine’s SmartHeart® Technology; Cardiosense’s Nationwide Heart Failure Study
Orthofix Launched the Galaxy Fixation Gemini System and Expanded Sterile Kit Offerings for Orthopedic Trauma Procedures On September 20, 2023, Orthofix Medical Inc., a leading global spine and orthopedics company, launched the Galaxy Fixation Gemini™ system. It is a stable external fixation system that ...
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Sep 21, 2023
Zepp Health Launched OTC Hearing Aids; Neoss Launched NeoScan 2000; FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S; Tasso Received CE Mark Certification for Tasso+; Neuralink’s First-in-human BCI trial; Creative Medical to Initiate a Phase I/II Clinical Trial of StemSpine
Zepp Health Launched a New Line of OTC Hearing Aids for its Zepp Clarity Brand On September 19, 2023, Zepp Clarity, a smart hearing solutions brand owned by Zepp Health, a health technology company, announced the launch of Zepp Clarity Pixie, a next-generation premium hearing solution. The Pixie, which ...
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Sep 19, 2023
FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®
EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...
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Sep 12, 2023
BMS’s LPA1 Antagonist; Alnylam’s KARDIA-1 Phase 2 Study; Day One Biopharma Sought FDA Approval for Tovorafenib; EMA Orphan Drug Designation to MaaT Pharma’s MaaT033; Lundbeck and Otsuka Announce Topline Results from Two Phase III Trials of Brexpiprazole + Sertraline; Phase III CheckMate – 227 Trial Show Durable, Long-Term Survival with Opdivo Plus Yervoy
Bristol Myers Squibb’s Investigational LPA1 Antagonist Reduces Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase II Study BMS-986278, a potential first-in-class oral lysophosphatidic acid receptor 1 (LPA1) antagonist, was studied in patients with progressive pulmonary fibrosis (PPF)...
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Sep 07, 2023
Boston Scientific’s WATCHMAN FLX™ Pro; Quest Diagnostics’s AAV Test; Vitestro Started A.D.O.P.T. Clinical Trial; Signia Introduces Hearing Aids; Laborie Medical to Acquire Urotronic; Synchron’s Brain-Computer Interface Trial
Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test On August 30, 2023, Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA). The enzyme-linked immunosor...
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Sep 05, 2023
Daiichi Sankyo’s Trastuzumab Deruxtecan; ODD to Bexmarilimab for AML; Roche’ Alecensa; Ergomed Aims To Go Private; Tagraxofusp Receives ODD in Japan for BPCDN; FDA Fast Track Designation to Abliva’s KL1333
FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...
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Aug 29, 2023
FDA Approves BMS’s Reblozyl for MDS; FDA Awards Orphan Drug Designation to NXC-201; Janssen Submits Supplemental NDA for Full Approval of BALVERSA; FDA Grants Fast Track Status to ALE.C04; FDA Orphan Drug Designation to Faron’s Bexmarilimab; FDA Clears IND Application for AHB-137
FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...
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Aug 22, 2023
Eylea HD Injection 8 Mg Approved By FDA; Veopoz Receives FDA Approval for CHAPLE Disease Treatment; FDA Places Second Partial Clinical Hold on AML Enrollment for Magrolimab Trials; FDA Approval to Incannex’s Sleep Apnoea Clinical Trial; FDA Orphan Drug Designation to Avidity’s AOC 1044; Orphan Drug Designation to CanariaBio’s MAb-AR20.5
Eylea HD Injection 8 Mg Approved By FDA for Treatment of Wet AMD, DME, and Diabetic Retinopathy The FDA has approved Regeneron Pharmaceuticals’ EYLEA HD (aflibercept) Injection of 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retin...
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Aug 17, 2023
4WEB Medical’s Cervical Spine Plating Solution; Viseon Launched Visualization System for Minimally Invasive Spine Surgery; ZimVie’s New Mobi-C Implant; GE HealthCare’s Wireless Monitoring Solution; Acorai’s Non-Invasive Intracardiac Pressure Monitor; CytoSorbents’s STAR-T Pivotal Trial
4WEB Medical Launched its Cervical Spine Plating Solution On August 15, 2023, 4WEB Medical, an orthopedic implant company focused on developing innovative implants that utilize its proprietary Truss Implant Technology™, launched the newest addition to the company's implant portfolio, the Cervical Spine Pla...
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Aug 15, 2023
J&J’s 2-in-1 Tablet for Prostate Cancer; FDA Approves TALVEY for Heavily Pretreated Multiple Myeloma; PDS Biotech Updated on VERSATILE-003 Trial; FDA Issues CRL to NDA for Avasopasem in Radiotherapy-Induced Severe Oral Mucositis in HNC; FDA Orphan Drug Designation to Genprex’s REQORSA; FDA Orphan Drug Designation to Bloomsbury’s BGT-OTCD
FDA Clears J&J’s 2-in-1 Tablet for Prostate Cancer Johnson & Johnson's Janssen Pharmaceutical Companies stated that the US Food and Drug Administration (FDA) had approved AKEEGA (niraparib and abiraterone acetate), the first-and-only dual-action tablet combining a PARP inhibitor including abiraterone ace...
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