FDA
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 10, 2023
Quest Introduced Consumer-Initiated Blood Test for Alzheimer’s Disease Risk Assessment; DuPont Acquires Spectrum Plastics; BD Received 510(k) Clearance for Molecular Combination Test; Natera Updates on Phase III ALTAIR Trial of Signatera; Anteris’ DurAVR transcatheter heart valve Trial
Quest Introduced First-To-Market Consumer-Initiated Blood Test for Alzheimer's Disease Risk Assessment on Questhealth Website On July 31, 2023, Quest Diagnostics, a leader in diagnostic information services, announced the introduction of the AD-Detect™ Test for Alzheimer's Disease on questhealth.com – the first ...
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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 27, 2023
VARON’s New VP Series Portable Oxygen Concentrator; Biostrap’s Wrist-Worn Digital Health Monitoring Device; MediView’s AR Navigation Platform; Beckman Coulter’s DxC 500 AU Chemistry Analyzer; Magnus Updated on Study Using SAINT Neuromodulation System; Francis Medical’s VAPOR 2 Pivotal Study
VARON Launched the Game-changer in the Field--New VP Series Portable Oxygen Concentrator On July 19, 2023, VARON, a leading oxygen concentrator manufacturer, announced the launch of a game-changer portable oxygen concentrator VP-2. A new member of the VP series, VP-2 is incorporated with innovative tech...
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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 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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