ELEVIDYS
Mon Nov 17 10:37 am
Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.
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FDA | What's New: Vaccines
What’s New for Biologics
Mon Nov 17 10:25 am
Drugs@FDA Data Files
Mon Nov 17 7:20 am
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD)
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ADYNOVATE
Fri Nov 14 5:32 pm
Product approval information is indicated for children and adults with hemophilia A (congenital factor VIII deficiency) for: (1) On-demand treatment and control of bleeding episodes; (2) Perioperative management; (3) Routine prophylaxis to reduce the frequency of bleeding episodes.
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FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients
Fri Nov 14 3:39 pm
In June 2025, FDA issued a safety communication, “FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS,” to provide information on two reports of fatal acute liver failure following treatment with Elevidys...
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FDA Approves New Safety Warning and Revised Indication that Limits Use for Elevidys Following Reports of Fatal Liver Injury
Fri Nov 14 1:44 pm
The U.S. Food and Drug Administration today announced it is taking action to approve new labeling submitted by the company that includes the addition of a Boxed Warning, the agency’s most prominent safety warning, to Elevidys (delandistrogene moxeparvovec-rokl), and that the indication section of th
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Public Meeting on the Reauthorization of the Biosimilar User Fee Act (BsUFA) - 12/03/2025
Fri Nov 14 1:42 pm
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years 2028 through 2032. The public meeting will be held on December 3, 2025, from 9 a.m. to 12 p.m ET.
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Cellular, Tissue, and Gene Therapies Advisory Committee October 31, 2023 Meeting Announcement - 10/31/2023
Wed Nov 12 12:33 pm
This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) October 31, 2023 meeting announcement and materials main page.
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eSubmitter Application History
Mon Nov 10 9:49 am
History of all updates to the application software in reverse chronological order by version number
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Konrad Rejdak, M.D., Ph.D. - 671405 - 05/29/2024
Mon Nov 10 8:37 am
Elecsys HTLV-I/II
Mon Nov 10 6:18 am
The Elecsys HTLV-I/II is an in vitro immunoassay for the qualitative detection of antibodies to HTLV-I and HTLV-II in human serum and plasma. Elecsys HTLV-I/II is intended to screen individual human donors, including volunteer donors of whole blood and blood components.
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ProQuad
Fri Nov 07 3:40 pm
The Approval Letter and Approved Final Draft Labeling for Merck's Efficacy Supplement for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®), to include concomitant administration with hepatitis A vaccine (VAQTA®) and/or pneumococcal conjugate vaccine (Prevnar®), use of ProQuad® in chi
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