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
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
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
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
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
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.
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
FDA Clears Breyanzi as the First CAR T‑Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma in the US | iPharmaCenter
FDA Greenlights Breyanzi: Pioneering CAR T-Cell Therapy for Marginal Zone Lymphoma The U.S. Food and Drug Administration has approved Breyanzi (lisocabtagene maraleucel) for adults battling relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy. This groundbreaking decision positions Breyanzi as the first CAR T-cell therapy approved in the U.S. for this challenging rare B-cell malignancy, offering new hope to patients with limit
US FDA Accepts AstraZeneca’s Baxdrostat for Priority Review in Resistant Hypertension
The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca’s New Drug Application (NDA) for baxdrostat under Priority Review , marking a key regulatory milestone for patients with hard‑to‑control or treatment‑resistant hypertension. The application seeks approval for baxdrostat as an add‑on therapy to existing antihypertensive treatments in adult patients whose blood pressure remains inadequately controlled despite standard care. Also read: Top 10 pharmaceutical c
FDA Approves Jaypirca for Relapsed or Refractory CLL/SLL Previously Treated with Covalent BTK Inhibitors | iPharmaCenter
The U.S. Food and Drug Administration has approved an expanded indication for Eli Lilly's Jaypirca (pirtobrutinib), making it the first and only non-covalent, reversible Bruton tyrosine kinase (BTK) inhibitor approved to treat adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously received covalent BTK inhibitor therapy. The approval also converts the company's December 2023 accelerated approval into a tradi