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
5 days ago2 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
FDA Grants Second Approval to Sotyktu in the US; approved for Adults with Active Psoriatic Arthritis
The U.S. Food and Drug Administration (FDA) has granted approval for Sotyktu (deucravacitinib), an oral, selective inhibitor of tyrosine kinase 2 (TYK2), for use in adult patients with active psoriatic arthritis (PsA). This marks the first approval of a TYK2 inhibitor for this condition in the United States. The decision was supported by positive outcomes from two pivotal Phase 3 clinical studies, POETYK PsA-1 and POETYK PsA-2, which evaluated the efficacy and safety of deucr
Mar 82 min read
FDA says no to AstraZeneca’s Saphnelo Subcutaneous Formulation for Lupus Patients | iPharmaCenter
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for AstraZeneca’s Biologics License Application (BLA) seeking approval of Saphnelo (anifrolumab) for subcutaneous administration in adults with systemic lupus erythematosus (SLE). This is despite Saphnelo SC meeting primary endpoint in clinical trial. AstraZeneca has provided the additional information requested and stated its commitment to working closely with the FDA to advance the appli
Feb 72 min read