XOLREMDI (mavorixafor) zol-REM-deeX4 Pharmaceuticals, Inc.Original Approval date: April 26, 2024 DRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? XOLREMDI is a prescription drug that increases the […]

EXBLIFEP (cefepime and enmetazobactam)EX-BLEE-FEPAllecra Therapeutics SAS Original Approval date: February 22, 2024 DRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? EXBLIFEP is a combination of cefepime […]

On this page: American medicine cabinets contain a growing choice of nonprescription, over-the-counter (OTC) medicines to treat an expanding range of ailments. OTC medicines often do […]

Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act NOTE: This list simply identifies […]

FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 [Page 111 STAT. 2296] Public Law 105-115 105th Congress SEC. 127. APPLICATION OF FEDERAL LAW TO PRACTICE OF […]

Submit Comments by 09/29/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

Below are frequently asked questions and the associated answers sorted by topic area.  Drug Review What information and types of notifications are provided to sponsors during […]

By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research CDER Director, Patrizia […]

FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program By: Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research […]