FDA
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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May 02, 2024
Xtant Medical’s SimipliGraft TM and SimpliMaxTM Launch; Perelel’s Fertility Support Products Expansion; Medtronic’s InceptivTM FDA Approval; GE Healthcare’s Vital Signs Monitor FDA 510(K) Clearance; Merck’s Pneumonia Vaccine Positive Results; Artivion’s Aortic Devices AATS Win
Xtant Medical Announced the Launch of SimipliGraft TM and SimpliMaxTM for Chronic and Acute Wounds On April 30, 2024, Xtant Medical Holdings, Inc., a global medical technology firm specializing in surgical remedies for spinal disorders, announced the complete commercial availability of two amniotic membran...
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Apr 30, 2024
X4 Pharmaceuticals’ XOLREMDI FDA Approval; ONO to Acquire Deciphera Pharmaceuticals; Johnson & Johnson’s SIRTURO CHMP Approval; BeiGene’s Tislelizumab EC Approval; Sanofi’s Rilzabrutinib LUNA 3 Phase III Trial
FDA Greenlights XOLREMDI Capsules from X4 Pharmaceuticals for WHIM Syndrome Treatment X4 Pharmaceuticals has declared that the FDA has granted approval for XOLREMDI™ (mavorixafor) capsules to be utilized in individuals aged 12 and above who have WHIM syndrome (characterized by warts, hypogammaglobulinemia, infec...
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Apr 25, 2024
iVEAcare’s $27.5 Million Series A Funding; AI Medical Service Joint Research Agreement with Mahidol University; CERENOVUS Launched Catheter; Cochlear FDA Clearance for The Osia System; Immunovia Announced Positive Results From The Model-Development Study; Hyalex Orthopaedics First Patients Treatment
iVEAcare Launched $27.5 Million Series A Funding from Leading Medtech Investors On April 24, 2024, iVEAcare, announced the closure of a $27.5 million Series A financing. The financing was led by Vensana Capital, which was joined by Treo Ventures, Hatteras Venture Partners, and an undisclosed strategic partner. i...
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Apr 23, 2024
Ipsen and Skyhawk Therapeutics Partnership; SynOx Therapeutics’ Phase III Trial; Roche’s Alecensa FDA Approval; AbbVie’s RINVOQ Phase III SELECT-GCA Trial; AskBio’s AB-1002 FDA Fast Track Designation
Ipsen Partners with Skyhawk Therapeutics for RNA-Focused Research in Rare Neurological Disorders Ipsen and Skyhawk Therapeutics have entered into an exclusive global partnership to explore and create new small molecules that can influence RNA for rare neurological conditions. Under this agreement, Ipsen has the ...
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