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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 …

FDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication Read More »

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.

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Rasonque (daraxonrasib), an oral treatment for adults with metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) who have received at least one previous treatment.

EMA has recommended granting a marketing authorisation in the European Union for Foundayo (orforglipron), an oral GLP-1 receptor agonist for weight management and treatment of type 2 diabetes in adults.

The U.S. Food and Drug Administration approved a new nonprescription eye drop treatment, Brytly, apraclonidine ophthalmic solution, 0.125%, for relief of eye redness due to minor irritations. This is the first nonprescription eye drop with apraclonidine.

On October 14, 2026, the Food and Drug Administration (FDA) approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or …

FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer Read More »