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April 9, 2021

FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

Remarks by Dr. Janet Woodcock to the 2021 Rx Drug Abuse and Heroin Summit – 04/08/2021

Remarks by Dr. Janet Woodcock Acting Commissioner of Food and Drugs April 8, 2021 (Remarks as prepared for delivery) Thank you.  It is an honor to […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: FDA approval of Fotivda (tivozanib) for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies

Podcast Welcome back to the DISCO, FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

FDA D.I.S.C.O. Burst: Approval of Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four lines of prior therapy

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 9, 2021

FDA D.I.S.C.O. Burst Edition: Libtayo (cemiplimab-rwlc) for first-line treatment of patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression with no eGFR, anaplastic lymphoma kinase or receptor tyrosine kinase aberrations

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]
April 8, 2021

About Mineral – 613984 – 04/07/2021

Product: Drugs Recipient: Recipient Name Hyun Eun Lee About Mineral 3063 W. Chapman Ave., #6301Orange, CA 92868United States [email protected] DATE:             April 7, 2021 RE:             […]
April 8, 2021

October – December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen Stevens-Johnson Syndrome FDA is evaluating the need for regulatory action. Ajovy (fremanezumab) Vyepti (eptinezumab) Anaphylactic reaction FDA is evaluating the need for regulatory action. Albuterol […]
April 8, 2021

Allure Imports – 613211 – 04/07/2021

Product: Animal & VeterinaryDrugs Recipient: Recipient Name Cory Chiarello Allure Imports 405 E Easterday Ave., Unit 2Sault Sainte Marie, MI 49783United States in[email protected] WARNING LETTER Date: […]
April 7, 2021

FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer

On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic […]
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