US FDA News

FDA clears Pluvicto earlier in PSMA positive metastatic prostate cancer

Badari Andukuri

Aug 4

FDA Approves Otsuka’s SIMTRIYO as First-in-Class NDSRI for ADHD

Badari Andukuri

Jul 27

FDA Approves First Oral PCSK9 Inhibitor, Signaling Shift in Dyslipidemia Treatment

Badari Andukuri

Jul 17

FDA Grants Landmark Approval for REVTORPYK: A New Standard for PIK3CA Wild-Type Breast Cancer

Badari Andukuri

Jul 15

FDA Approval of Sarclisa Escena Marks Shift Toward Subcutaneous Oncology Delivery | iPharmaCenter

Badari Andukuri

Jul 14

FDA Approves KEYTRUDA-Padcev Combo as First Perioperative Standard for Muscle-Invasive Bladder Cancer

Badari Andukuri

Jul 11

FDA Clears Sanofi’s Tzield as First Disease-Modifying Therapy for Stage 3 Type 1 Diabetes | iPharmaCenter

Badari Andukuri

Jun 17

FDA Approves Datroway as First TROP2-Directed ADC for First-Line Metastatic Triple-Negative Breast Cancer in Non-PD-1/PD-L1 Candidates

ipharmaservices

May 22

Baxfendy (baxdrostat) Approved in the US as First Aldosterone Synthase Inhibitor for Uncontrolled Hypertension | iPharmaCenter

Badari Andukuri

May 18

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

Badari Andukuri

May 16

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

ipharmaservices

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

ipharmaservices

Dec 23, 2025

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

Badari Andukuri

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

ipharmaservices

Dec 4, 2025

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

ipharmaservices

Dec 4, 2025

FDA clears Pluvicto earlier in PSMA positive metastatic prostate cancer

FDA Approves Otsuka’s SIMTRIYO as First-in-Class NDSRI for ADHD

FDA Approves First Oral PCSK9 Inhibitor, Signaling Shift in Dyslipidemia Treatment

FDA Grants Landmark Approval for REVTORPYK: A New Standard for PIK3CA Wild-Type Breast Cancer

FDA Approval of Sarclisa Escena Marks Shift Toward Subcutaneous Oncology Delivery | iPharmaCenter

FDA Approves KEYTRUDA-Padcev Combo as First Perioperative Standard for Muscle-Invasive Bladder Cancer

FDA Clears Sanofi’s Tzield as First Disease-Modifying Therapy for Stage 3 Type 1 Diabetes | iPharmaCenter

FDA Approves Datroway as First TROP2-Directed ADC for First-Line Metastatic Triple-Negative Breast Cancer in Non-PD-1/PD-L1 Candidates

Baxfendy (baxdrostat) Approved in the US as First Aldosterone Synthase Inhibitor for Uncontrolled Hypertension | iPharmaCenter

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

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