FDA
Aug 20, 2024
Gilead’s Livdelzi FDA Approval for Primary Biliary Cholangitis; Incyte and Syndax’s Niktimvo Approved for Graft-Versus-Host Disease; FDA Lifts Hold on BioNTech and MediLink’s ADC Cancer Trial; FDA Approves IMFINZI for Resectable Lung Cancer; Yutrepia Receives Tentative Approval for PAH and PH-ILD
Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (...
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Aug 13, 2024
FDA Approves Ascendis Pharma’s YORVIPATH; ARS Pharma Gets FDA Green Light for First Nasal Spray; FDA Rejects Lykos’ MDMA-Assisted PTSD Therapy; Novartis’ FABHALTA Receives FDA Accelerated Approval; Servier Snags FDA Approval for Voranigo
Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency Ascendis Pharma A/S has announced that the FDA has approved YORVIPATH (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. YORVIPATH, a prodrug of parathyroid hormone (PTH[1-34]), is adm...
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Aug 08, 2024
MIMEDX Launches HELIOGENTM Fibrillar Collagen Matrix; DocGo Launches Mobile X-ray Program; Labcrop’s FDA De Novo Marketing Authorization; Inspire Medical Systems Receives FDA Approval; Alcyone Therapeutics Announces Continued Enrollment Approval from the FDA; Lunit’s AI for Tuberculosis Detection
MIMEDX Announced the Launch of HELIOGENTM Fibrillar Collagen Matrix On July 31, 2024, MiMedx Group, Inc. launched HELIOGEN™ Fibrillar Collagen Matrix, a particulate xenograft product designed to treat complex wounds, especially in surgical environments. HELIOGEN is a shelf-stable product that contains Type...
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Aug 06, 2024
Tecelra by Adaptimmune: First FDA-Approved Engineered Cell Therapy for Solid Tumors; GSK’s JEMPERLI Approved for Endometrial Cancer; MBX Biosciences Secures $63.5M in Series C for PEP™ Platform; FDA Stops Actinium’s Radiotherapy Blood Cancer Plans, Pushing Partnering Shift; Otsuka Acquires Jnana for Up to $1.1B, Enhancing Drug Discovery
Adaptimmune’s TECELRA Becomes First FDA-Approved Engineered Cell Therapy for Solid Tumors Adaptimmune Therapeutics announced that the FDA has approved (afamitresgene autoleucel), which will be marketed under the brand name TECELRA, for the treatment of unresectable or metastatic synovial sarcoma. This marks the ...
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Jul 25, 2024
STRATA Skin Sciences’ XTRAC Momentum™ 1.0 Device Approved in Japan; eCential Robotics Received FDA 510(k) Clearance for Spine Navigation and Robotic-Assistance Device; MicroVention Announced the Results of the Clinical Evaluation of WEB™ 17 Device; Neuspera Medical, Inc.’s SANS-UUI Pivotal Clinical Trial; GE HealthCare Announced an Agreement to Acquire the Clinical Artificial Intelligence Business; Sutter Health Implemented World’s First Wearable Doppler Ultrasound Patch
STRATA Skin Sciences Announced That the Ministry of Health, Labor and Welfare Approved the XTRAC Momentum™ 1.0 Device in Japan, Specifically Designed to Treat Inflammatory Skin Conditions On July 22, 2024, STRATA Skin Sciences, Inc., a medical technology company specializing in developing, commercializing, and m...
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Jul 18, 2024
Inspira™ Approval of INSPIRA™ ART100 System; Oticon Medical’s Sentio™ System Received Regulatory Clearance; SpineGuard Filed its “510K” Dossier in the US; Vectorious Medical Technologies’ V-LAP Left Atrial Pressure Sensor Successful Implantation; Bedal International Raised $11 Million; Mytonomy Inc. Agreement With Vizient, Inc.
Inspira™ Secured Approval From Israeli Authorities for its INSPIRA™ ART100 System On July 11, 2024, Inspira™ Technologies OXY B.H.N. Ltd., a pioneering medical technology company, secured a pivotal milestone with the receipt of the Israeli Ministry of Health's medical devices and accessories ("AMAR") approval fo...
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Jul 16, 2024
Immutep’ First-Line Treatment Positive Outcomes; Pfizer’s Once-Daily Oral GLP-1 Agonist Danuglipron; FDA Issues Complete Response Letter to Novo Nordisk; Arcutis’ ZORYVE® Cream 0.15% FDA Approval; NICE Recommends Ebglyss For Moderate To Severe Atopic Dermatitis
Immutep Announces Promising Outcomes for First-Line Treatment in PD-L1 Negative Head and Neck Squamous Cell Carcinoma Patients Immutep Limited announced positive results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, evaluating eftilagimod alfa (efti) combined with MSD’s anti-PD-1 therapy KEYTR...
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Jul 09, 2024
Lilly’s Morphic Acquisition; IDEAYA’s IDE397 Positive Phase II Trial Result; XPOVIO (selinexor) Approval in China; Roche to Reintroduce Susvimo in the US; Dupixent EU Approval
Lilly Strengthens IBD Treatment Portfolio with Morphic Acquisition Eli Lilly and Company and Morphic Holding, Inc. announced a definitive agreement for Lilly to acquire Morphic, a biopharmaceutical company developing oral integrin therapies for serious chronic diseases. Lilly will initiate a tender offer to acqu...
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Jul 02, 2024
Eisai Announces Solo Development of Farletuzumab Ecteribulin (FZEC); Johnson & Johnson’s Nipocalimab Phase III Trial; Merck’s WINREVAIR EU CHMP Recommendation; Verona Pharma’s Ohtuvayre FDA Approval; AstraZeneca’s Lynparza and Imfinzi EU Approval
Eisai Announces Solo Venture for Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate Eisai Co., Ltd. announced the termination of its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), previously known as MORAb-202, an ...
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Jun 27, 2024
Alcon’s 510(k) Clearance From the FDA; Globus Medical Received FDA Clearance; UK Pioneers First Skull-Mounted Epilepsy Device for Child; The Initiation of a Significant Clinical Trial of 3d Printed Models; Esaote Unveiled the Cutting-Edge Mylab™E80 @Sirm Ultrasound Device For 2024; Medasense Unveiled a Transformative Partnership With Nihon Kohden Corporation
Alcon's Newest Technological Marvels, Unity VCS, and Unity CS, Achieved 510(k) Clearance From the U.S. FDA, Paving the Way for New Advancements On June 24, 2024, Alcon, the foremost name in eye care with a mission to help people see brilliantly, revealed that the U.S. Food and Drug Administration (FDA) had...
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