Medicines Articles
The U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
The U.S. Food and Drug Administration has approved KEYTRUDA and KEYTRUDA QLEX in combination with Padcev, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.
A recent study shows the use of hormone therapy in postmenopausal women was associated with a significantly higher incidence and risk of autoimmune diseases.
FDA has accepted a supplemental new drug application for leniolisib to treat activated phosphoinositide 3-kinase delta syndrome, or APDS, in children aged 4 to 11 years.
The U.S. Food and Drug Administration has approved Libtayo (cemiplimab-rwlc) for the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.
The U.S. Food and Drug Administration has granted fast track designation for Greenwich LifeSciences’ lead immunotherapy candidate GLSI-100 in HLA-A*02–positive, HER2-positive breast cancer patients who have completed standard HER2-targeted therapy.
The U.S. Food and Drug Administration has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA (pembrolizumab).
The U.S. Food and Drug Administration has expanded the approval of recombinant von Willebrand factor, marketed as Vonvendi.
The U.S. Food and Drug Administration (FDA) has approved the biologics license application for once weekly lecanemab-irmb subcutaneous injection (LEQEMBI IQLIK, pronounced “I Click”) for maintenance dosing.
The U.S. Food and Drug Administration has approved Sanofi’s Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
A groundbreaking retrospective cohort analysis of more than four million children offers compelling evidence that there is no significant association between early antibiotic exposure and heightened risk of autoimmune diseases in children.
The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use.