FDA Clears Sanofi’s Tzield as First Disease-Modifying Therapy for Stage 3 Type 1 Diabetes | iPharmaCenter
Sanofi has secured US regulatory clearance for Tzield as a treatment aimed at modifying disease progression in children recently diagnosed with stage 3 type 1 diabetes. The authorization marks the first time a therapy has been approved in this setting to help preserve the body’s own insulin production. The US Food and Drug Administration granted accelerated approval for Tzield for use in patients aged 8 to 17 years who have been newly diagnosed with stage 3 type 1 diabetes.
50 minutes ago2 min read
FDA Approves Datroway as First TROP2-Directed ADC for First-Line Metastatic Triple-Negative Breast Cancer in Non-PD-1/PD-L1 Candidates
The US Food and Drug Administration has approved Datroway, developed by AstraZeneca and Daiichi Sankyo, as the first TROP2-directed antibody drug conjugate cleared for first-line treatment of metastatic triple-negative breast cancer in patients who are not suitable candidates for PD-1 or PD-L1 inhibitor therapy. This approval marks a significant shift in how this difficult-to-treat cancer may be managed going forward. What is Datroway and Why Does This Approval Matter? Datr
May 222 min read
Baxfendy (baxdrostat) Approved in the US as First Aldosterone Synthase Inhibitor for Uncontrolled Hypertension | iPharmaCenter
Baxfendy FDA Approval for Hypertension AstraZeneca has received US FDA approval for Baxfendy (baxdrostat), the first and only aldosterone synthase inhibitor (ASI) indicated for the treatment of hypertension in adults whose blood pressure remains uncontrolled despite standard therapies. Baxfendy is approved for use in combination with other antihypertensive medications, offering a new treatment option for patients with resistant or difficult-to-control hypertension. Also re
May 182 min read
BeOne Medicines’ Beqalzi (sonrotoclax) Gets FDA Approval as First BCL2 Inhibitor for Relapsed or Refractory Mantle Cell Lymphoma | iPharmaCenter
BeOne Medicines announced that the U.S. FDA has granted accelerated approval to Beqalzi (sonrotoclax), the first and only BCL2 inhibitor approved for relapsed or refractory (R/R) mantle cell lymphoma (MCL) in the United States. Also read: Top 10 U.S. healthcare companies by 2026 revenue Beqalzi is approved for adult patients who have received at least two prior systemic therapies, including a Bruton’s tyrosine kinase (BTK) inhibitor. This marks the first new BCL2 inhibitor ap
May 162 min read
Foundayo (orforglipron) Wins FDA Approval as First Anytime GLP‑1 Tablet for Weight Loss | iPharmaCenter
The U.S. FDA has approved Foundayo (orforglipron), a once‑daily GLP‑1 tablet for chronic weight management in adults with obesity or overweight and weight‑related comorbidities. It is currently the only GLP‑1 pill for weight loss that can be taken at any time of day without specific restrictions on food or water intake. Also read: New Hope for GVHD Patients as Rezurock Wins EU Approval Backed by the phase 3 ATTAIN programme, Foundayo delivered clinically meaningful and sustai
Apr 82 min read