Drug approvals, label changes, and FDA drug news.
The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma.
On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melan
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for pati
Data Descriptions updated (February 24, 2017)
The Drug Supply Chain Security Act (DSCSA) recognizes the role of small dispensers in the drug supply chain. Learn more.
FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to small business dispensers (e.g. pharmacies), and where applicable their trading partners, until November 27, 2027. This exemption allows time to complete the small dispensers assessment , publish the final assessme
FDA's annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. Join us April 22-23, 2026.
FDA’s Actions to Address Unapproved Thyroid Medications
The FDA approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults.
FDA is working with other federal agencies to make sure adequate supplies of medicine and vaccines are available to the American public.
Antiseptic FDA Letters
The completion of the monograph for over-the-counter (OTC) Consumer and Health Care Antiseptic Products is part of FDA’s larger, ongoing review of antiseptic active ingredients to determine whether these active ingredients are safe and effective for use in antiseptic drug products.
FDA is reimagining the IND Process Through Clarifying Requirements and Launching the Expedited IND Pilot.
The Center for Drug Evaluation and Research (CDER) takes an active role in helping prepare the nation to respond to terrorist events, emerging health threats, and emergency response to natural and man-made crises.
Publications from Office of Biostatistics Staff
Quality Information for Applicants | Chemistry, Manufacturing, and Controls (NDAs, ANDAs, BLAs, and IND applications)
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.
There are three types of submissions needed to register an establishment and list a drug with FDA. Learn more.
Establishments, with certain exemptions, engaged in manufacturing, repacking, relabeling or salvaging drugs for U.S. distribution is required to register with FDA.
Labeler codes are used to propose and assign national drug codes (NDCs) for drugs and are required prior to listing a drug or reserving an NDC with FDA for the first time. Learn more.
Reserving a national drug code is an optional step that provides an NDC up to two years before a drug is ready to launch. Learn more.
All registered establishments must list every drug they produce for U.S. commercial distribution under their own labeler code. Learn more.
In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs.
We are advancing transformation through a more aligned, risk-informed, and transparent approach to inspectional operations that is already taking shape across the FDA.