Action FDA has approved Joenja (leniolisib) tablets as the first treatment for activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years of age […]
Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
What is a compounded drug? Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the […]
Update [1/8/2020] The U.S. Food and Drug Administration is alerting health care professionals and consumers to Mylan’s voluntary recall of prescription nizatidine capsules. The medicines may […]
Summary Company Announcement Date: March 22, 2023 FDA Publish Date: March 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) […]
On March 22, 2023, the Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced […]
Quick Links Notices The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and […]
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