Otolaryngology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

AUCATZYL Approved for R/R B-ALL; FDA Accepts NDA for Unicycive’s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sjögren’s Disease; AbbVie’s Schizophrenia Drug Fails Phase Studies

FDA Approves Autolus's AUCATZYL for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia Autolus Therapeutics has achieved a significant milestone with FDA approval for AUCATZYL (obecabtagene autoleucel), a next-generation CAR T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). This approval, granted based on results from the FELIX clinical trial, highlights the therapy's efficacy, with a 63% overall complete remission rate in the efficacy-evaluable patient cohort. Notably, AUCATZYL also demonstrated a favorable safety profile with low rates of severe Cytokine Release Syndrome and Immune Effector Cell-Associated...

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Johnson & Johnson’s TREMFYA Approved for Ulcerative Colitis; Roche’s Tecentriq Hybreza Approved as Subcutaneous Anti-PD-(L)1; OCREVUS ZUNOVO Receives Twice-a-Year Multiple Sclerosis Injection Approval; Lilly’s EBGLYSS Greenlit for Moderate-to-Severe Atopic Dermatitis; DUPIXENT Approved for Adolescents with Chronic Rhinosinusitis

Ears to the Future: Evaluating Key Advancements and Trends Driving the Audiology Devices Market Growth

MedTech News for Neoss, Tasso, Neuralink, Zepp

Zepp Health Launched OTC Hearing Aids; Neoss Launched NeoScan 2000; FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S; Tasso Received CE Mark Certification for Tasso+; Neuralink’s First-in-human BCI trial; Creative Medical to Initiate a Phase I/II Clinical Trial of StemSpine

MedTech News for Vitestro, Signia, Synchron

Boston Scientific’s WATCHMAN FLX™ Pro; Quest Diagnostics’s AAV Test; Vitestro Started A.D.O.P.T. Clinical Trial; Signia Introduces Hearing Aids; Laborie Medical to Acquire Urotronic; Synchron’s Brain-Computer Interface Trial

MedTech News and Updates for Mindray, Getinge, Gore, CoreLink

Mindray’s TE Air Handheld Ultrasound System; Getinge’s iCast™ Covered Stent System; Clinical Trial Update for the FLASH Proton Therapy for Cancers in the Bones; Gore’s Gore® Viafort Vascular Stent IVC Study; CoreLink’s Siber® Ti—3D Printed SI Joint Fusion System; USound and Partners’s Next-Generation Over-the-Counter Hearing Aids

Biologics in the Nasal Polyposis Treatment Market

Amgen’s Olpasiran Candidate; GSK’s Novel Antibiotic for Urinary Tract Infections; AstraZeneca and Sanofi’s Beyfortus Approval; FDA Orphan Designation to Anavex’s Anavex2-73; FDA Rare Pediatric Disease Designation to Sensorion’s OTOF-GT; GSK’s Blenrep Fails in Phase III Trial in R/R Multiple Myeloma

MedTech News for AngioDynamics, Ameda, Pfizer, Cochlear

AngioDynamics’s AlphaVac F18 PE System; Pfizer’s RSVpreF/PF-06928316 Trial; Intelligent Ultrasound’s ScanNav Anatomy PNB; FDA Approves the Cochlear Nucleus 8 Sound Processor; Ameda’s Pearl Breast Pump; J&J to Buy Abiomed; Thermo Fisher Scientific to Acquire The Binding Site Group

Key Devices in Hearing Loss Management Market

Evaluating the Growing Role of Devices in the Rehabilitation of Hearing Impairment

MedTech News for Miracor, Oticon, and Medtronic

Miracor Medical’s Picso Pivotal Study; Medtronic’s Extravascular ICD; Galaxy Medical’s CENTAURI Pulsed Electric Field System; UltraSight’s Novel Cardiac AI Technology; Oticon Launched the World’s Smallest Hearing Aid; Medtronic Completes Acquisition of Affera

pharma news and updates for AstraZeneca, AbbVie, Sandoz, Incyte, Venatorx, and Bayer

AstraZeneca and Merck’s Lynparza; Venatorx’s cefepime-taniborbactam; AbbVie’s Qulipta; AstraZeneca’s IL-5 inhibitor Fasenra; Sandoz Acquires Coalesce; Incyte’s Opxelura; Bayer’s Nubeqa; NICE Rejects Keytruda Plus Chemotherapy

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Bausch + Lomb’s LuxSmart Intraocular Lenses; Movair’s Luisa Life Supporting Ventilator; Cochlear’s Nucleus and Baha Systems; Laborie Acquires Pelvalon; Know Labs’s SARS-CoV-2 Research; Syntellix’s MAGNEZIX;

Analysing the Treatment Approaches in the Hearing Loss Market and Key Companies in the Domain

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RETINA-AI Health declares positive results; Medtronic’s Hugo robotic-assisted surgery system; Boston Scientific acquires Devoro Medical; Paige obtains first-ever FDA approval

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Otolaryngology

AUCATZYL Approved for R/R B-ALL; FDA Accepts NDA for Unicycive’s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sjögren’s Disease; AbbVie’s Schizophrenia Drug Fails Phase Studies

Ears to the Future: Evaluating Key Advancements and Trends Driving the Audiology Devices Market Growth

Zepp Health Launched OTC Hearing Aids; Neoss Launched NeoScan 2000; FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S; Tasso Received CE Mark Certification for Tasso+; Neuralink’s First-in-human BCI trial; Creative Medical to Initiate a Phase I/II Clinical Trial of StemSpine

Boston Scientific’s WATCHMAN FLX™ Pro; Quest Diagnostics’s AAV Test; Vitestro Started A.D.O.P.T. Clinical Trial; Signia Introduces Hearing Aids; Laborie Medical to Acquire Urotronic; Synchron’s Brain-Computer Interface Trial

Biologics Spark Market Interest In The Nasal Polyposis Treatment Space

How is Active Implantable Medical Devices Market Evolving?

Chronic Smell and Flavor Loss Treatment Market Garners Attention amid the Pandemic Chaos

More Views & Analysis

AngioDynamics’s AlphaVac F18 PE System; Pfizer’s RSVpreF/PF-06928316 Trial; Intelligent Ultrasound’s ScanNav Anatomy PNB; FDA Approves the Cochlear Nucleus 8 Sound Processor; Ameda’s Pearl Breast Pump; J&J to Buy Abiomed; Thermo Fisher Scientific to Acquire The Binding Site Group

Evaluating the Growing Role of Devices in the Rehabilitation of Hearing Impairment

Miracor Medical’s Picso Pivotal Study; Medtronic’s Extravascular ICD; Galaxy Medical’s CENTAURI Pulsed Electric Field System; UltraSight’s Novel Cardiac AI Technology; Oticon Launched the World’s Smallest Hearing Aid; Medtronic Completes Acquisition of Affera

AstraZeneca and Merck’s Lynparza; Venatorx’s cefepime-taniborbactam; AbbVie’s Qulipta; AstraZeneca’s IL-5 inhibitor Fasenra; Sandoz Acquires Coalesce; Incyte’s Opxelura; Bayer’s Nubeqa; NICE Rejects Keytruda Plus Chemotherapy

Bausch + Lomb’s LuxSmart Intraocular Lenses; Movair’s Luisa Life Supporting Ventilator; Cochlear’s Nucleus and Baha Systems; Laborie Acquires Pelvalon; Know Labs’s SARS-CoV-2 Research; Syntellix’s MAGNEZIX;

Analysing the Treatment Approaches in the Hearing Loss Market and Key Companies in the Domain

RETINA-AI Health declares positive results; Medtronic’s Hugo robotic-assisted surgery system; Boston Scientific acquires Devoro Medical; Paige obtains first-ever FDA approval

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