Oncology

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Notizia - Recent Pharma, Healthcare and Biotech Happenings

Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), each occurring after two or more lines of systemic therapy. The sole concern for approval is associated with the status of enrollment in the confirmatory trials. The CRLs, one for R/R FL and one for R/R DLBCL did not highlight any concerns regarding the clinical effectiveness or safety of odro...

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Pharma News Updates for Merck, Sanofi, GSK, Hinova, Endogena, Amylyx

Merck’s Keytruda Wins Another FDA Approval; Sanofi Pauses Trial of Myasthenia Gravis Drug, tolebrutinib; FDA Approves GlaxoSmithKline’s Jesduvroq; FDA IND Application Clearance for Hinova’s HP518; FDA Fast Track Designation to Endogena’s EA-2353; Amylyx Updates on Global Phase 3 PHOENIX Trial

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Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

Latest Pharma News and Updates for BeiGene, Seagen, Alnylam, Roche, Astellas

BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy

MedTech News and Updates for Vivos, Arthrex, Chindex, Glaukos, Zimmer Biomet

Vivos Therapeutics ‘s DNA Oral Appliance for the Treatment of OSA; Arthrex’s TightRope Implant for Pediatric ACL Surgery; Chindex Medical Acquired 10 ViewRay MRIdian Systems; Zimmer Biomet to Acquire Embody; GE HealthCare to buy IMACTIS; Glaukos Announced the iDose TR Exchange Trial

Latest Pharma News and Updates for Ipsen, Chiesi, Takeda, ACELYRIN, Lantern Pharma

Ipsen to Acquire Albireo; Chiesi Farmaceutici to Buy Amryt Pharma; Takeda Presents Phase III Results of TAK-755 for cTTP; ACELYRIN Acquires ValenzaBio; FDA Approves LEQEMBI for Alzheimer’s Disease; Orphan Drug Designation to Lantern Pharma’s LP-284 for MLL

MedTech News and Updates for Inspira, Burning Rock, Verana, liberDi, Innova

Inspira and Terumo Signed Strategic Agreement; Cook Medical’s New Bipolar Electrodes Portfolio; Verana Health and Sight Sciences Collaborated on Glaucoma Research; Burning Rock’s OverC Multi-Cancer Detection Blood Test; Innova Vascular’s Thrombectomy System; liberDi’s Digital Dialysis System

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ENHERTU’s Journey in Cancer Treatment and Management

Pharma News for Gilead, Roche, AstraZeneca, Genentech, Mirati, Pfizer

Gilead Sciences’ Sunlenca Approval; FDA Approves Roche’s CD20xCD3 Bispecific Antibody Lunsumio; EU Approves AstraZeneca’s Imfinzi Plus Chemo; Pfizer Files Blockbuster Hope Etrasimod for Ulcerative Colitis; FDA Approves Mosunetuzumab for R/F Follicular Lymphoma; FDA Breakthrough Therapy Designation to Adagrasib Plus Cetuximab for KRAS G12C–Mutated Advanced CRC

Awaited Approval for New Therapies for Head and Neck Cancer Treatment – A Race Against Time!

Nuclear Medicine Radiopharmaceuticals Benefit, Applications, Key Companies, and Market Forecast

How is Nuclear Medicine Bringing Groundbreaking Transformation in the Healthcare Industry?

Pharma News and Updates for AbbVie, Ferring, Merck, CSL, Amicus, Takeda

Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result

Bispecific Antibodies in DLBCL, Opportunities and Challenges

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Oncology

Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition

Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval

BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy

Vivos Therapeutics ‘s DNA Oral Appliance for the Treatment of OSA; Arthrex’s TightRope Implant for Pediatric ACL Surgery; Chindex Medical Acquired 10 ViewRay MRIdian Systems; Zimmer Biomet to Acquire Embody; GE HealthCare to buy IMACTIS; Glaukos Announced the iDose TR Exchange Trial

Ipsen to Acquire Albireo; Chiesi Farmaceutici to Buy Amryt Pharma; Takeda Presents Phase III Results of TAK-755 for cTTP; ACELYRIN Acquires ValenzaBio; FDA Approves LEQEMBI for Alzheimer’s Disease; Orphan Drug Designation to Lantern Pharma’s LP-284 for MLL

Inspira and Terumo Signed Strategic Agreement; Cook Medical’s New Bipolar Electrodes Portfolio; Verana Health and Sight Sciences Collaborated on Glaucoma Research; Burning Rock’s OverC Multi-Cancer Detection Blood Test; Innova Vascular’s Thrombectomy System; liberDi’s Digital Dialysis System

ENHERTU’s Journey in Cancer Treatment and Management

More Views & Analysis

Awaited Approval for New Therapies for Head and Neck Cancer Treatment – A Race Against Time!

How is Nuclear Medicine Bringing Groundbreaking Transformation in the Healthcare Industry?

Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result

ASH 2022- Emergence of Bispecific antibodies in DLBCL: Prospects, Opportunities, and Challenges

ASH 2022: Preview of the Top Abstracts In the Follicular Lymphoma (FL) Therapeutics Market

ASH 2022: Roche’s Polivy vs ADC Therapeutics’ Zynlonta, Antibody-Drug Conjugates (ADC) in R/R DLBCL

ASH 2022: Yescarta emerging as the CAR-T leader in DLBCL; Failure of Kymriah in early lines of DLBCL

ASH 2022 Annual Meeting – Insights Into Major Diffuse Large B-cell Lymphoma (DLBCL) Abstract and Breakthroughs

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