Study Shows Hormone Therapy Is Linked to Autoimmune Disease
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 Accepts NDA for Leniolisib to Treat Children with APDS
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.
FDA Approves Libtayo for Cutaneous Squamous Call Carcinoma
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.
FDA Fast Tracks Immunotherapy for HER2-Positive Breast Cancer Recurrence
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.
FDA Approves Merck’s KEYTRUDA QLEX for Solid Tumor Indications
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).
FDA Expands Approval for Recombinant VWF
The U.S. Food and Drug Administration has expanded the approval of recombinant von Willebrand factor, marketed as Vonvendi.
FDA Approves LEQEMBI IQLIK to Treat Early Alzheimer’s Disease
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.
FDA Approves First BTK Inhibitor for ITP
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.
Study Finds No Connection Between Antibiotic Use and Autoimmune Disease in Children
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.
FDA Requires Major Changes to Opioid Pain Medical Labeling
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.