FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children 4-11 years who weigh at least 27 kg. Joenja was first approved in 2023 for the same indication in patients 12 years and older at a dose of 70 mg orally twice a day. Children 4-11 …
On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.
The U.S. Food and Drug Administration issued a final administrative order removing two active ingredients — aminobenzoic acid (PABA) and trolamine salicylate — from the list of ingredients that can be used in sunscreen drug products under the OTC sunscreen monograph. FDA determined that the risks associated with use of these active ingredients in sunscreen …
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
The U.S. Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies from birth up to four weeks weighing at least 2 kg, in combination with other antiretroviral agents. Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.
The U.S. Food and Drug Administration (FDA) has approved Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids.
First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
European approval of the IGF-1-derived small molecule analogue offers a new option for patients aged five and over with the rare neurodevelopmental disorder.
Potential first-in-class treatment HM17321 offers a non-incretin mechanism of action and differentiated profile from existing GLP-1-based treatments for obesity.
