news
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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Aug 08, 2023
FDA Approves ZURZUVAE for Postpartum Depression; Astellas Drug Acquired in $5.9B Deal Wins FDA Approval; FDA Clearance to Phase III Study of Lisaftoclax; FDA Issues CRL to BLA Resubmission for Remestemcel-L; Bavarian Nordic Updated on its Chikungunya Virus Vaccine; FDA Orphan Drug Designation to ABM-1310
FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily t...
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Aug 03, 2023
Icotec’s VADER Pedicle System; Terumo BCT’ Reveos Automated Whole Blood Processing System; Genesis MedTech’s J-Valve Transfemoral System; STARmed Launched STARmed America in the USA
Genesis MedTech Announces FDA Breakthrough Device Designation for the J-Valve™ Transfemoral System Genesis MedTech, a leading medical device company, announced that the US Food and Drug Administration (FDA) has designated its J-ValveTM Transfemoral (TF) System as a Breakthrough Device. This innovative heart valv...
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Aug 01, 2023
FDA Expands GSK’s Jemperli Approval; Biogen to Acquire Reata Pharma; Enhertu Shows Survival Boost in HER2+ Solid Tumors; FDA Rejects Citius’ Revived IL-2 Therapy; FDA Fast Track designation to IVS-3001 for RCC; EU Orphan Drug Designation to Biohaven’s Taldefgrobep Alfa
FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...
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Jul 20, 2023
Relievant Medsystems Launched Ablation System; Thermo Fisher’s Reproductive Health Assays; EarliTec’s Next-Generation EarliPoint Evaluation for ASD; FDA Cleared ReddyPort® Non-Invasive Ventilation Device; EndoTheia’s Novel Medical Device for Endoscopic Surgery; Neurolief’s MOOD Trial Interim Analysis
Relievant Medsystems Launched New Tools for its Ablation System On June 14, 2023, Relievant Medsystems announced that it launched its next-generation access instruments for the Intracept procedure. Chronic vertebrogenic low back pain is treated with Intracept, a minimally invasive, same-day, outpatient proced...
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