FDA Clears AstraZeneca's Etcamah for a Genetically Defined Subset of First-Line Breast Cancer | iPharmaCenter

Sep 5

Ionis Wins First Ever FDA Approval for an Alexander Disease Treatment, Marking a Turning Point for a Disease With No Prior Options

Sep 4

FDA Approves Takeda’s MIMRYLO for Polycythemia Vera | iPharmaCenter

Aug 30

FDA Approves Revolution Medicines’ RASONQUE for Metastatic Pancreatic Cancer | iPharmaCenter

Aug 27

FDA Approves Johnson and Johnson’s IMAAVY for Warm Autoimmune Hemolytic Anemia | iPharmaCenter

Aug 26

Regeneron's Pasatru wins FDA nod as second FOP therapy, first to cut flare-ups and new bone lesions

Aug 20

FDA Clears Ultragenyx Gene Therapy for Glycogen Storage Disease Type Ia

Aug 19

FDA Grants Accelerated Approval to Zenbexus Combination for Relapsed Multiple Myeloma | iPharmaCenter

Aug 14

FDA clears Pluvicto earlier in PSMA positive metastatic prostate cancer

Aug 4

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

Jul 27

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

Jul 17

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

Jul 15

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

Jul 14

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

Jul 11

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

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

May 22

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

May 18

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

May 16

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

Apr 8

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

Mar 8

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

Feb 7

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

Jan 17

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

Dec 23, 2025

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

Dec 23, 2025

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

Dec 23, 2025

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

Dec 5, 2025

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

Dec 4, 2025

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

Dec 4, 2025

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

Dec 2, 2025

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

Dec 1, 2025

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

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)

Nov 25, 2025

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

Nov 23, 2025

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

Nov 19, 2025

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

Apr 3, 2025

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

Mar 5, 2025

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

Feb 3, 2025

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

Jan 29, 2025

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

Jan 3, 2025

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

Dec 23, 2024

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

Oct 13, 2024

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

Oct 13, 2024

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

Oct 9, 2024

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

Aug 24, 2024

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

Aug 8, 2024

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

Aug 8, 2024

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

Aug 5, 2024

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

Jul 4, 2024

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

Jun 20, 2024

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

Jun 19, 2024