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June 14, 2021

Other OMUFA Fee-Related Questions

Q1. How does a person make payment to satisfy fiscal year (FY) 2021 OMUFA facility fee(s)? Persons can submit payment to fulfill FY 2021 OMUFA facility […]
June 11, 2021

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

Summary Company Announcement Date: June 11, 2021 FDA Publish Date: June 11, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Nitrosodimethylamine (NDMA) impurities […]
June 11, 2021

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

On April 21, 2020, the Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA, Pharmacyclics LLC) to include its combination with rituximab for the initial […]
June 11, 2021

FDA approves new dosing regimen for pembrolizumab

On April 28, 2020, the Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA, […]
June 11, 2021

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, […]
June 11, 2021

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTA, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) […]
June 9, 2021

Oncology (Cancer) / Hematologic Malignancies Approval Notifications

FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma Food and Drug Administration granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics, Inc.), a kinase inhibitor for […]
June 9, 2021

Core Patient-Reported Outcomes in Cancer Clinical Trials

Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations to […]
June 8, 2021

Electronic Registration and Listing Compliance Program

Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, […]
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