FDA Approves Upadacitinib for Adults With Moderately to Severely Active Crohn Disease
May 18th 2023In clinical trials of patients with Crohn disease, upadacitinib demonstrated early and long-term symptom relief, as well a visible reduction of damage to the intestinal lining caused by excess inflammation.
Read More
Pegfilgrastim Biosimilar for Treatment of Neutropenia Launches
May 17th 2023Pegfilgrastim-pbbk is a leukocyte growth factor developed to reduce the onset of infection in patients with non-myeloid malignancies administered myelosuppressive anticancer medications associated with a clinically significant rate of febrile neutropenia.
Read More
FDA Approves First Respiratory Syncytial Virus Vaccine for Adults Aged 60 Years and Older
May 3rd 2023Arexvy is the first respiratory syncytial virus (RSV) vaccine approved in the United States for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
Read More
Pneumococcal Vaccine Candidate Shows Promise in Adults Aged 65 Years and Older
April 20th 2023VAX-24 is designed to prevent invasive pneumococcal disease and pneumonia, which can be most serious for infants, young children, older adults, and those with immune deficiencies or some chronic health conditions.
Read More
Accelerated Approvals Withdrawn for Ibrutinib in Mantle Cell Lymphoma, Marginal Zone Lymphoma
April 7th 2023Accelerated approvals for ibrutinib (Imbruvica) for patients with mantle cell lymphoma and with marginal zone lymphoma voluntarily withdrawn based on data that were insufficient to support conversion to full approval.
Read More
FDA Approves Evinacumab-dgnb for Young Children With Homozygous Familial Hypercholesterolemia
March 22nd 2023Evinacumab-dgnb (Evkeeza; Regeneron Pharmaceuticals, Inc) is the first FDA-approved treatment indicated for children as young as 5 years of age to treat dangerously high levels of LDL-C.
Read More
FDA Approves Expanded Indication for Abemaciclib in HR+/HER2–, High-Risk Breast Cancer
March 6th 2023Indication for abemaciclib (Verzenio; Eli Lilly and Company) in combination with endocrine therapy expanded for the adjuvant treatment of adults with hormone receptor–positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer with a high risk of recurrence.
Read More
Study Shows PCV13 Followed by PPSV23 Protects Against Pneumococcal Diseases in Patients With SCD
March 6th 2023The immunological efficacy of the 13-valent conjugate pneumococcal vaccine followed by 23-valent polysaccharide vaccine has been poorly documented in adult patients with sickle cell disease.
Read More