EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential vaccines against Ebola disease caused by Bundibugyo virus (BDBV). The paper was developed following a scientific consultation with relevant experts, hosted by AMA, EMA and the World Health …
AMA and EMA issue joint guidance on Ebola vaccine development Read More »
In the FDA’s latest From a Global Perspective, Marta Sokolowska from the FDA and Steffen Thirstrup from the European Medicines Agency (EMA) provide their “Regulatory Perspectives on Herbal Medicinal / Botanical Drug Development.” This conversation between leaders of each agency focused on the recent FDA/EMA workshop on this topic and how the regulators are working …
FDA and EMA Discussion on Herbal & Botanical Drug Products Read More »
On October 26, 2026, the Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) in combination with enzalutamide for the treatment of adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer with homologous recombination repair (HRR) gene mutations, as detected by an FDA-authorized test.
On October 16, 2026, the Food and Drug Administration granted traditional approval to pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥13 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-authorized test, that have progressed following prior treatment and …
The webpage outlines FDA’s plan and ongoing activities to engage stakeholders on identifying approved prescription drugs that may be promising candidates for nonprescription marketing and provides answers to frequently asked questions about the nonprescription drug development process.
Today, the FDA announced its FY 2027 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. The FDA determined the priority initiatives in collaboration with industry and the public, including feedback received during the FY 2026 Generic Drug Science and Research Initiatives Public Workshop.
On October 19, 2026, the Food and Drug Administration granted accelerated approval to dostarlimab (Jemperli, GlaxoSmithKline LLC) for adults with Stage II/III locally advanced rectal cancer (LARC) that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA authorized test for solid tumors.
