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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 […]
November 8, 2022

FDA alerts health care professionals of risks to patients exposed to xylazine in illicit drugs

[11-8-2022] Health care professionals should be cautious of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses, as naloxone may not be able to […]
November 8, 2022

Omega & Delta Co., Inc. – 636606 – 11/02/2022

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Ruben De Quesada Recipient Title General Manager Omega & Delta Co., Inc. Carr. 887 Km 0 […]
November 8, 2022

The Anthos Group, Inc. – 636846 – 11/03/2022

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Shan Umer Recipient Title President The Anthos Group, Inc. 705 N Douglas StreetEl Segundo, CA 90245United […]
November 8, 2022

Abraxis Bioscience LLC – 633713 – 10/31/2022

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Giovanni Caforio Recipient Title Chief Executive Officer Abraxis Bioscience LLC 620 N 51st Ave.Phoenix, […]
November 8, 2022

Sameness Evaluations in an ANDA — Active Ingredients

Submit Comments by 01/08/2023 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 […]
November 7, 2022

Audio Transcript | The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities

Joan: Welcome to the CDER Small Business and Industry Assistance (SBIA) Chronicles Podcast Series. Today’s topic: The FDA Compounding Incidents Program: Adverse Events Associated with Compounded […]
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