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 has approved Hovilpri (pritelivir) tablets for adults with weakened immune systems (i.e., immunocompromised patients) who have mucocutaneous lesions caused by herpes simplex virus (HSV) infection and have not responded to other therapies (acyclovir, valacyclovir, or famciclovir). Mucocutaneous lesions occur on skin or mucosal surfaces, such as lips, nostrils, eyes and genitals.
The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027. The initiative contributes to higher-quality applications and more efficient clinical trial assessment processes, by strengthening cooperation across the European medicines regulatory network.
The FDA issued a final guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers. This guidance provides biological product manufacturers with recommendations on the nature and type of information they should provide FDA to support postapproval manufacturing changes to licensed (approved) biosimilar and interchangeable biosimilar products.
