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
1 day 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
5 days ago2 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
Sun Pharma Launches UNLOXCYT in the U.S. for Advanced Cutaneous Squamous Cell Carcinoma
Sun Pharmaceutical Industries has introduced UNLOXCYT (cosibelimab) in the United States for adult patients diagnosed with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are ineligible for curative surgery or radiation therapy. iPharmaCenter Consulting: Find services here Updated FDA Label Reflects Long-Term Efficacy The U.S. FDA recently approved an updated label for UNLOXCYT following the release of extended follow-up data from
Jan 172 min read
Boehringer Ingelheim Bolsters Pulmonary Fibrosis Portfolio with Jascayd Approval for Progressive Cases
Boehringer Ingelheim announced US Food and Drug Administration clearance for Jascayd (nerandomilast) tablets to treat progressive pulmonary fibrosis in adults. This marks the second indication for the therapy, following its recent approval for idiopathic pulmonary fibrosis. Jascayd introduces the first selective phosphodiesterase 4B inhibitor with both immune-modulating and anti-scarring properties approved for this serious lung disorder. FIBRONEER-ILD Trial Supports Approv
Dec 23, 20252 min read
FDA Clears Wegovy Pill as First Oral GLP-1 for US Weight Management
Novo Nordisk announced US Food and Drug Administration approval for the once-daily Wegovy pill (oral semaglutide 25 mg). This marks the first oral glucagon-like peptide-1 receptor agonist approved specifically for chronic weight control and cardiovascular risk reduction in adults with obesity or overweight plus comorbidities. The therapy targets excess body weight reduction, long-term weight maintenance, and lowering major adverse cardiovascular events in eligible patients.
Dec 23, 20252 min read
US FDA Grants Approval to Exdensur, ultra-long acting biologic for Severe Eosinophilic Asthma
GSK announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for adults and adolescents aged 12 years and older with severe asthma characterized by an eosinophilic phenotype. Exdensur stands out as the first ultra-long-acting biologic therapy for severe asthma, designed for twice-yearly dosing, offering patients a more convenient treatment schedule compared with currently available biologics. Clinical
Dec 23, 20252 min read