news
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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Jul 18, 2023
Lilly to Acquire Versanis; FDA Approves Beyfortus for RSV in Infants; Alnylam Presented Updates on Interim Phase 1 Results for ALN-APP; FDA Accepts NDA for Rivoceranib Plus Camrelizumab; FDA Fast Track Designation to Karyopharm’s Selinexor; Adcentrx’s IND Application for ADRX-0706
Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases Eli Lilly & Company and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical firm focused on the discovery of novel medications for the treatment of cardiometab...
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Jul 13, 2023
ResMed Acquired Somnoware; Stryker Launched Q Guidance System; AlloSource’s AceConnex Pre-Sutured Fascia; Urotronic’s Optilume BPH Catheter System; Verve Medical’s Pivotal Trial of RPD Renal Pelvic Denervation System; OncoBeta Provided Update on Rhenium-SCT
ResMed Acquired Somnoware, a Leader in Digital Sleep and Respiratory Care Diagnostics Software On July 05, 2023, ResMed acquired privately held Somnoware, a US leader in sleep and respiratory care diagnostics software. The Somnoware software streamlines the processes of physicians as well as sleep and p...
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Jul 11, 2023
FDA Grants Priority Review for Zolbetuximab BLA; FDA Traditional Approval for LEQEMBI for Alzheimer’s Disease; Iovance Announces Regulatory and Clinical Updates for TIL Therapy in Advanced NSCLC; Biophytis Seeks FDA Approval to Launch Phase 3 Study of Potential Treatment of Sarcopenia; Orphan Drug Designation to Marker Therapeutics’s MT-401 for AML Treatment; Axsome Therapeutics Initiates Phase 3 Trial of Solriamfetol for ADHD
Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...
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Jul 06, 2023
Enovis Acquires Novastep; Rockwell Medical Announced Collaboration with B. Braun; Dexcom G7 Received Health Canada Approval for Next-Generation CGM; Abbott’s World’s First Dual Chamber Leadless Pacemaker; Elios Vision’s Pivotal Trial of ELIOS; Synergy Spine’s Synergy Disc 2-Level IDE Trial
Enovis completed the acquisition of Novastep On June 29, 2023, Enovis, one of the largest orthopedic device companies in the world, announced that the company had completed the purchase of Novastep and its foot and ankle minimally invasive surgical (MIS) platform, which was first announced in April 2023. ...
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Jul 04, 2023
First Gene Therapy for Severe Hemophilia A; FDA Approves CellTrans’s Type 1 Diabetes Cellular Therapy; FDA Approve Amneal’s Parkinson’s Drug Over Safety Concerns; NLS Pharmaceutics’s Phase III Clinical Trials of Quilience; Genenta Science’s Temferon for the Treatment of Glioma; FDA Fast Track Designation to GSK’s Gonorrhea Drug
FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...
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Jun 27, 2023
FDA Approves Jardiance for Type 2 Diabetes; FDA Approves Pfizer’s LITFULO for Alopecia Areata; Sarepta Therapeutics’s ELEVIDYS Approval; Tonix Pharmaceuticals to Acquire Two Migraine Products from Upsher-Smith; FibroGen’s Phase 3 ZEPHYRUS-1 Study of Pamrevlumab; FDA Orphan Drug Designation to ERAS-801 for Malignant Glioma
FDA Approves Jardiance for the Treatment of Type 2 Diabetes in Children 10 Years and Older Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance® (empagliflozin) 10 mg and 25 mg tablets to decrease blood sugar together with diet and exercise in children 10 years and older w...
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Jun 13, 2023
FDA Fast Track Status to Kyverna’s KYV-101; Annovis’s Phase III Study for Buntanetap; Gilteritinib Demonstrated Benefit in AML Patients; FDA Orphan Drug Designation to DTx Pharma’s DTx-1252; FibroGen’s LELANTOS-1 Phase 3 Clinical Study Result
FDA Grants Fast Track Status to KYV-101 for Refractory Lupus Nephritis Treatment Kyverna Therapeutics announced that the FDA has given Fast Track status to KYV-101, a treatment for patients suffering from resistant lupus nephritis (LN). KYV-101 is an innovative therapy that uses anti-CD19 chimeric antigen recept...
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Jun 08, 2023
Olympus’s Next Generation Electrosurgical Generator; Biocomposites Acquires Artoss GmbH; Artelon’s FlexBand, FlexPatch, and FlexBand Plus; Masimo’s Radius VSM; Gore’s GORE VIAFORT Vascular Stent; Synergy Spine Solutions’s 1-Level IDE Trial
Olympus Launched Next Generation Electrosurgical Generator On June 06, 2023, Olympus Corporation, a global medical technology company, launched its newest electrosurgical generator, ESG-410 for use in the treatment of bladder cancer and enlarged prostate. By offering a variety of resection loops, band electro...
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