EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and national control laboratories to continue to advance and implement alternative methods or approaches to animal testing throughout the lifecycle of human medicines, wherever, and as soon as possible.
By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This follows a multistakeholder workshop held on 28 and 29 September in Amsterdam where participants converged on a series of priority actions.
On October 2, 2026, the Food and Drug Administration approved pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion.
The U.S. Food and Drug Administration (FDA) approved Camzyos (mavacamten) capsules as the first treatment for children with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Camzyos was first approved for adults in 2022 and is now approved for both adults and pediatric patients weighing at least 30 kg (approximately 66 lbs) …
FDA has approved Gazyva (obinutuzumab) injection to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid-dependent, cFDA has approved Gazyva (obinutuzumab) injection to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or …
FDA Approves Drug to Treat Idiopathic Nephrotic Syndrome in Patients 2 Years and Older Read More »
The U.S. Food and Drug Administration (FDA) has approved Pasatru (garetosmab-grts) to reduce new heterotopic ossification (bone formation outside the skeleton) and reduce clinician-assessed disease flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). Pasatru is the second drug approved for patients with this very rare disease.
On September 24, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with lenvatinib (Lenvima, Eisai Inc.) for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
On September 23, 2026, the Food and Drug Administration approved lirafugratinib (Lyrfigtu, Elevar Therapeutics, Inc.), a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.
