US FDA News

BeOne Medicines’ Beqalzi (sonrotoclax) Gets FDA Approval as First BCL2 Inhibitor for Relapsed or Refractory Mantle Cell Lymphoma | iPharmaCenter

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2 days ago

Foundayo (orforglipron) Wins FDA Approval as First Anytime GLP‑1 Tablet for Weight Loss | iPharmaCenter

Badari Andukuri

Apr 8

FDA Grants Second Approval to Sotyktu in the US; approved for Adults with Active Psoriatic Arthritis

Badari Andukuri

Mar 8

FDA says no to AstraZeneca’s Saphnelo Subcutaneous Formulation for Lupus Patients | iPharmaCenter

Badari Andukuri

Feb 7

Sun Pharma Launches UNLOXCYT in the U.S. for Advanced Cutaneous Squamous Cell Carcinoma

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Jan 17

Boehringer Ingelheim Bolsters Pulmonary Fibrosis Portfolio with Jascayd Approval for Progressive Cases

Badari Andukuri

Dec 23, 2025

FDA Clears Wegovy Pill as First Oral GLP-1 for US Weight Management

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Dec 23, 2025

US FDA Grants Approval to Exdensur, ultra-long acting biologic for Severe Eosinophilic Asthma

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Dec 23, 2025

FDA Clears Breyanzi as the First CAR T‑Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma in the US | iPharmaCenter

Badari Andukuri

Dec 5, 2025

US FDA Accepts AstraZeneca’s Baxdrostat for Priority Review in Resistant Hypertension

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Dec 4, 2025

FDA Approves Jaypirca for Relapsed or Refractory CLL/SLL Previously Treated with Covalent BTK Inhibitors | iPharmaCenter

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Dec 4, 2025

Dual Special Needs Plans (D-SNPs) and Key 2026 Changes: What Dual Eligibles Need to Know During Medicare Enrollment | iPharmaCenter

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Dec 2, 2025

FDA Clears Imfinzi as First Perioperative Immunotherapy for Resectable Gastric and GEJ Cancers | iPharmaCenter

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Dec 1, 2025

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

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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

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BeOne Medicines’ Beqalzi (sonrotoclax) Gets FDA Approval as First BCL2 Inhibitor for Relapsed or Refractory Mantle Cell Lymphoma | iPharmaCenter

Foundayo (orforglipron) Wins FDA Approval as First Anytime GLP‑1 Tablet for Weight Loss | iPharmaCenter

FDA Grants Second Approval to Sotyktu in the US; approved for Adults with Active Psoriatic Arthritis

FDA says no to AstraZeneca’s Saphnelo Subcutaneous Formulation for Lupus Patients | iPharmaCenter

Sun Pharma Launches UNLOXCYT in the U.S. for Advanced Cutaneous Squamous Cell Carcinoma

Boehringer Ingelheim Bolsters Pulmonary Fibrosis Portfolio with Jascayd Approval for Progressive Cases

FDA Clears Wegovy Pill as First Oral GLP-1 for US Weight Management

US FDA Grants Approval to Exdensur, ultra-long acting biologic for Severe Eosinophilic Asthma

FDA Clears Breyanzi as the First CAR T‑Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma in the US | iPharmaCenter

US FDA Accepts AstraZeneca’s Baxdrostat for Priority Review in Resistant Hypertension

FDA Approves Jaypirca for Relapsed or Refractory CLL/SLL Previously Treated with Covalent BTK Inhibitors | iPharmaCenter

Dual Special Needs Plans (D-SNPs) and Key 2026 Changes: What Dual Eligibles Need to Know During Medicare Enrollment | iPharmaCenter

FDA Clears Imfinzi as First Perioperative Immunotherapy for Resectable Gastric and GEJ Cancers | iPharmaCenter

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

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

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

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

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

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

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

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