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November 14, 2022

Resources for Information | Approved Drugs

[email protected] information about drugs approved for human use in the United States: Drug information, Regulatory history, Most recent FDA-approved Prescribing Information and patient labeling, and Reviews […]
November 14, 2022

Drug Trials Snapshot: TEPMETKO

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
November 14, 2022

Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards – 01/13/2023

On This Page Date: January 13, 2023 Time: 11:00 AM – 12:00 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS WEBINAR Sponsors […]
November 10, 2022

FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer

On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult […]
November 10, 2022

Tainted Sexual Enhancement Products

11/10/2022 Sangter Natural Male Energy Supplement contains hidden drug ingredient 7/28/2022 Honeymoon Exclusive For Men & Women contains hidden drug ingredients 7/15/2022 Adam’s Secret Extra Strength […]
November 10, 2022

Public Notification: Sangter Natural Male Energy Supplement contains hidden drug ingredient

[11-10-2022] The Food and Drug Administration is advising consumers not to purchase or use Sangter Natural Male Energy Supplement, a product promoted and sold for sexual […]
November 10, 2022

FDA approves brentuximab vedotin in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma

On November 10, 2022, the Food and Drug Administration approved brentuximab vedotin (Adcetris, Seagen, Inc.) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric […]
November 8, 2022

FDA approves cemiplimab-rwlc in combination with platinum-based chemotherapy for non-small cell lung cancer

On November 8, 2022, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for adult patients with advanced non-small […]
November 8, 2022

Cross Labeling Oncology Drugs in Combination Regimens

Docket Number: FDA-2020-D-2107 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Drug approvals in oncology often build […]
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