US FDA News 2/4

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FDA Greenlights Kygevvi as Pioneering Therapy for Thymidine Kinase 2 Deficiency in Adults and Kids | iPharmaCenter

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Nov 28, 2025

Novartis Receives FDA Approval for Itvisma, Expanding Access to Gene Replacement Therapy for People of All Ages Living with Spinal Muscular Atrophy (SMA)

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Nov 25, 2025

FDA Approves KEYTRUDA and KEYTRUDA QLEX in Combination with Padcev as Perioperative Treatment for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer | iPharmaCenter

FDA Approves KEYTRUDA and KEYTRUDA QLEX in Combination with Padcev as Perioperative Treatment for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer | iPharmaCenter

FDA Approves KEYTRUDA and KEYTRUDA QLEX in Combination with Padcev as Perioperative Treatment for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer | iPharmaCenter

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Nov 23, 2025

FDA Approves Epkinly in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma | iPharmaCenter

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Nov 19, 2025

FDA Approves Novartis' Pluvicto for Earlier Treatment of Prostate Cancer | iPharmaCenter

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Apr 3, 2025

Tevimbra Receives U.S. Approval for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy | iPharmaCenter

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Mar 5, 2025

AstraZeneca's ADC Enhertu is now approved in US for HR-positive, HER2-low or ultra low breast cancer | iPharmaCenter

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Feb 3, 2025

FDA Grants Approval for Enhertu in HER2-Positive Breast Cancer Following Endocrine Therapy | iPharmaCenter

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Jan 29, 2025

BeiGene's PD-L1 inhibitor Tevimbra approved in the US for advanced gastric or gastroesophageal junction (G/GEJ) cancers | iPharmaCenter

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Jan 3, 2025

Lilly Secures FDA Approval for Zepbound in Obstructive Sleep Apnea, Outpacing Novo Nordisk | Pharma Breaking News | iPharmaCenter

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Dec 23, 2024

US FDA Approved Pfizer's Hympavzi for hemophilia A or B, who do not have inhibitors | FDA Approved | iPharmaCenter

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Oct 13, 2024

Roche aims to strengthen its breast cancer portfolio with the approval of Itovebi | FDA Approval | iPharmaCenter

Roche aims to strengthen its breast cancer portfolio with the approval of Itovebi | FDA Approval | iPharmaCenter

Roche aims to strengthen its breast cancer portfolio with the approval of Itovebi | FDA Approval | iPharmaCenter

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Oct 13, 2024

US FDA Approved Opdivo as perioperative treatment in patients with resectable non-small cell lung cancer | iPharmaCenter

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Oct 9, 2024

FDA Grants Accelerated Approval to Gilead’s Livdelzi for PBC, Marking Breakthrough in Liver Disease Treatment | iPharmaCenter

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Aug 24, 2024

Novartis Gains FDA Accelerated Approval for Fabhalta (iptacopan), a Complement Inhibitor for Reducing Proteinuria in Primary IgA Nephropathy (IgAN)

Novartis Gains FDA Accelerated Approval for Fabhalta (iptacopan), a Complement Inhibitor for Reducing Proteinuria in Primary IgA Nephropathy (IgAN)

Novartis Gains FDA Accelerated Approval for Fabhalta (iptacopan), a Complement Inhibitor for Reducing Proteinuria in Primary IgA Nephropathy (IgAN)

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Aug 8, 2024

FDA Approved Sun Pharma's Leqselvi (deuruxolitinib) for Severe Alopecia Areata

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Aug 8, 2024

US FDA Approves Expanded Use of Jemperli Plus Chemotherapy for Endometrial Cancer

US FDA Approves Expanded Use of Jemperli Plus Chemotherapy for Endometrial Cancer

US FDA Approves Expanded Use of Jemperli Plus Chemotherapy for Endometrial Cancer

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Aug 5, 2024

FDA Approves Lilly's Kisunla for Early Symptomatic Alzheimer's Disease

FDA Approves Lilly's Kisunla for Early Symptomatic Alzheimer's Disease

FDA Approves Lilly's Kisunla for Early Symptomatic Alzheimer's Disease

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Jul 4, 2024

Imfinzi approved for mismatch repair deficient endometrial cancer, fifth indication for AZ's blockbuster | iPharmaCenter

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Jun 20, 2024

FDA Approved Skyrizi for Ulcerative Colitis, Enhancing AbbVie's Inflammatory Bowel Disease Portfolio

FDA Approved Skyrizi for Ulcerative Colitis, Enhancing AbbVie's Inflammatory Bowel Disease Portfolio

FDA Approved Skyrizi for Ulcerative Colitis, Enhancing AbbVie's Inflammatory Bowel Disease Portfolio

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Jun 19, 2024

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