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FDA Novel Drug Approvals 2025

The FDA's Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025, meaning they were new and never before marketed in the U.S. The agency has released a report detailing these approvals, including drug names, active ingredients, and their approved uses.

FDA Novel Drug Approvals 2024

The FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in 2024, representing new molecular entities never before marketed in the U.S. This notice provides a list of these approvals and links to detailed reports and drug information.

FDA Novel Drug Approvals in 2023

The FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023, representing new therapies not previously marketed in the U.S. The agency released a report detailing these approvals and their uses.

FDA Novel Drug Approvals in 2022

The FDA's Center for Drug Evaluation and Research (CDER) approved 37 novel drugs in 2022, including new molecular entities (NMEs) and new therapeutic biological products (BLAs). This notice summarizes these approvals and provides a link to the full report.

NIH Reminder: IRB Approval Certification Required Before Award

The National Institutes of Health (NIH) issued a notice reminding the extramural research community that certification of Institutional Review Board (IRB) approval is required before award for nonexempt human subjects research. Funds cannot be used for such research without this certification, which must be the date of final IRB approval, not pending or expired.

NIH Extends Common Forms Timeline for Biographical Sketch and Other Support

The National Institutes of Health (NIH) has extended the leniency period for implementing Common Forms for Biographical Sketch and Current and Pending (Other) Support until May 2026. This notice adjusts the original January 25, 2026 deadline to allow the extramural community more time for adoption and compliance.

NIH Removes Advanced Permission for Conference Grant Applications

The National Institutes of Health (NIH) has removed the requirement for advanced permission for conference grant applications under activity codes R13 and U13. This change aims to reduce administrative burden for applicants, with modifications to the NIH Grants Policy Statement and relevant NOFOs forthcoming.

NIH Correction: Salary Limitation for Grants and Cooperative Agreements FY 2026

The National Institutes of Health (NIH) issued a correction to its guidance on salary limitations for grants and cooperative agreements for Fiscal Year 2026. The correction adjusts the effective date for the Executive Level II salary limitation of $228,000 from January 11, 2026, to January 1, 2026.

Public Consultations on Drug Development Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is seeking public input on proposed guidelines related to drug development standards. This consultation aims to gather feedback on new and revised guidelines before their finalization.

ICH Guidelines Overview

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines across quality, safety, efficacy, and multidisciplinary areas. These guidelines aim to harmonize technical requirements for pharmaceutical registration globally.