FDA What's New: Drugs

Activities Report of the Generic Drug Program (FY 2025) – FDARA Title VIII Sections 807 and 805
Thu Mar 05 3:05 pm
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).
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Activities Report of the Generic Drug Program | FDARA Title VIII Sections 807 and 805
Thu Mar 05 3:05 pm
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs).
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Generic Drug Facilities, Sites and Organization Lists
Thu Mar 05 3:02 pm
Generic Drug Facilities, Sites and Organization Lists
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Verified Clinical Benefit | Cancer Accelerated Approvals
Thu Mar 05 2:46 pm
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
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Patient-Focused Drug Development Glossary
Thu Mar 05 2:22 pm
This glossary defines terms that will be used in the series of methodological Patient-Focused Drug Development (PFDD) FDA guidance documents that are required by the 21st Century Cures Act, and part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA
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CDER Data Standards Program
Thu Mar 05 2:17 pm
CDER Data Standards Program
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Data Standards Program Strategic Plan and Board
Thu Mar 05 2:16 pm
The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.
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Ongoing | Cancer Accelerated Approvals
Thu Mar 05 2:02 pm
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.
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Oncology (Cancer)/Hematologic Malignancies Approval Notifications
Thu Mar 05 1:53 pm
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
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What's New Related to Drugs
Thu Mar 05 1:52 pm
Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma
Thu Mar 05 1:49 pm
On March 5, 2026, the Food and Drug Administration approved teclistamab (Tecvayli, Janssen Biotech, Inc.) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
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Premium Health Management Inc. dba Premium Health - 721474 - 02/20/2026
Thu Mar 05 1:42 pm
Failure to Register and List/Misbranded

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