US FDA News

top of page

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

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

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

Badari Andukuri

1 day ago

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

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

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

Badari Andukuri

2 days ago

FDA Approves Takeda’s MIMRYLO for Polycythemia Vera | iPharmaCenter

FDA Approves Takeda’s MIMRYLO for Polycythemia Vera | iPharmaCenter

FDA Approves Takeda’s MIMRYLO for Polycythemia Vera | iPharmaCenter

Badari Andukuri

7 days ago

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

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

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

Badari Andukuri

Aug 27

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

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

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

Badari Andukuri

Aug 26

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

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

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

Badari Andukuri

Aug 20

FDA Clears Ultragenyx Gene Therapy for Glycogen Storage Disease Type Ia

FDA Clears Ultragenyx Gene Therapy for Glycogen Storage Disease Type Ia

FDA Clears Ultragenyx Gene Therapy for Glycogen Storage Disease Type Ia

Badari Andukuri

Aug 19

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

Badari Andukuri

Aug 14

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

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

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

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

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

Badari Andukuri

Mar 8

bottom of page