FDA
Jun 06, 2024
Stryker’s LIFEPAK 35 Monitor/Defibrillator; Qiagen’s QIAstat-Dx Respiratory Panel; Evolution Optiks’s 510(k) Clearance; Microbot Medical Endovascular Surgical Robot Trial; Nexalin’s Insomnia and Anxiety Therapy Headset Clinical Trial; KORU Medical Systems’ Study With Commercialized Oncology Biologics
Stryker Released LIFEPAK 35 Monitor/Defibrillator On June 04, 2024, Stryker, a global leader in medical technologies, announced the launch of the LIFEPAK 35 monitor/defibrillator. This latest addition to their monitor/defibrillator lineup features advanced technology and is designed on an intuitive, modern...
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Jun 04, 2024
Moderna’s mRESVIA(R) FDA Approval; Novartis Scemblix® Phase III Data; Kite’s Tecartus for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia; Astellas’ Zolbetuximab Biologics License Application; CHMP Recommends AstraZeneca’s Tagrisso
FDA Greenlights Moderna's RSV Vaccine mRESVIA(R) Moderna, Inc. has announced that the FDA has approved mRESVIA (mRNA-1345), an mRNA-based vaccine for respiratory syncytial virus (RSV), to protect adults aged 60 and over from lower respiratory tract infections caused by RSV. This approval, granted under a breakth...
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May 30, 2024
Solis Mammography’s Acquisition of MUSIC Imaging Center; Nikon’s SI-PH Phase Condenser Accessory Option; Teijin Launch Surgical Patch; Terumo Cardiovascular’s FDA 510(K) Clearance; Spineart’s 510(k) Clearance; Ceretrieve’s Success in FIH Ischemic Stroke Cases
Solis Mammography Announced Acquisition of MUSIC Imaging Center in Gainesville, Florida On May 28, 2024, Solis Mammography announced the acquisition of the MUSIC Mammography and Ultrasound Imaging Center in Gainesville, Florida. For more than 10 years, MUSIC has provided patients with an advanced standard ...
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May 28, 2024
AstraZeneca’s Tropion-Lung01 Phase III Trial Positive Outcomes; Biogen’s LEQEMBI South Korea Approval; AltruBio’s $225M Series B Funding; GSK’s Depemokimab Positive Phase III Severe Asthma Results; Roche’s Inavolisib FDA Breakthrough Therapy Designation
The Tropion-Lung01 Phase III Trial Reveals that Datopotamab Deruxtecan Significantly Enhanced Overall Survival in Advanced Nonsquamous NSCLC Patients Compared to Chemotherapy The high-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which had previously met the dual primary endpoint o...
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May 23, 2024
Laborie’s Enhanced Gastrointestinal Diagnostics; Carestream’s Image Suite MR 10 Software Launch; Implicity’s Heart Failure Algorithm FDA 510(k) Approval; AngioDynamics’ AlphaVac F1885 System CE Mark Approval; HeartBeam’s Artificial Intelligence Algorithm for Arrhythmias; Onward ARC-EX Nerve Stim Hit Pivotal Trial
Laborie Launched Solar Compact System and Solar Anorectal Manometry Catheter for Enhanced Gastrointestinal Diagnostics On May 20, 2024, Laborie Medical Technologies Corp., launched the Solar Compact System and Solar Anorectal Manometry Catheter, the first disposable HRAM catheter on the market. These devices sig...
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May 21, 2024
Amgen’s IMDELLTRA FDA Approval; J&J’s Proteologix Acquisition; Bristol Myers Squibb’s BREYANZI FDA Approval; AbbVie and Gilgamesh Pharmaceuticals’ Agreement; Eisai’s LEQEMBI FDA Fast Track Status
IMDELLTRA Receives FDA Approval as the First T-Cell Engager Therapy for Advanced Small Cell Lung Cancer Amgen has reported that the FDA has approved IMDELLTRA™ (tarlatamab-dlle) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following pl...
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May 16, 2024
Siemens Healthineers USD 314 Million Investment; Samsung Medison’s Sonio Acquisition; Leo Cancer Care’s Upright Technology Clearance; OrthoXel’s Vertex Hip Fracture Nail FDA 510 (k) Clearance; SPR Therapeutics’ PNS Pain Relief Device Positive Data; Valneva’s Chikungunya Vaccine Positive Pivotal Phase III Data
Siemens Healthineers Invested USD 314 Million in New MRI Manufacturing Plant On May 15, 2024, Siemens Healthineers announced that it had invested USD 314 million in a new MRI manufacturing plant in the UK. The facility in Oxford, England, which Siemens anticipates opening in 2026, will develop technology to redu...
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May 14, 2024
Takeda and AC Immune’s Alzheimer’s Deal; Eli Lilly’s Donanemab FDA Review; Bristol Myers Squibb’s Phase III CheckMate -73L Trial Result; Regeneron Pharmaceuticals’ Dupixent sBLA; Excision BioTherapeutics’ EBT-101 Phase I/II Trial Results
Takeda and AC Immune Ink Exclusive Deal for Active Immunotherapy in Alzheimer’s, Focusing on Amyloid Beta Takeda and AC Immune SA have unveiled an exclusive global option and licensing pact concerning AC Immune’s active immunotherapies directed at harmful variants of amyloid beta (Abeta), notably ACI-24.060, int...
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May 09, 2024
Monteris Smallest Brain Laser Probe Launch; Vesica Health’s AssureMDx Test Launch; Anaut’s Eureka α Japanese Regulatory Approval; Geneoscopy’s Labcorp-Partnered Colon Cancer Test FDA Approval; Novel Omeza® OCM™ Diabetic Foot Ulcers Results; LEO Pharma Phase III Plaque Psoriasis Trial Results
Monteris Launched Smallest Brain Laser Probe on the Market On May 01, 2024, Monteris Medical launched the NeuroBlate® NB3™ FullFire® 1.6mm laser probe, the company’s latest product line innovation for use with their market-leading NeuroBlate System. The NB3 laser probe, which integrates Monteris' patented coo...
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May 07, 2024
Boehringer Ingelheim’s Diabetic Macular Ischemia Study; Novartis’ Mariana Oncology Acquisition; Astellas and Poseida Therapeutics Partnership; Prime Medicine’s PM359 IND; Pfizer’s TIVDAK FDA Approval
Boehringer Ingelheim Announces Promising Findings From Groundbreaking Study on Diabetic Macular Ischemia Boehringer Ingelheim released encouraging results from the HORNBILL Phase I/IIa trial of BI 764524, marking the pioneering investigation into a potential therapy for individuals with diabetic macular is...
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