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July 13, 2021

UPDATED TIME INFORMATION: July 15, 2021 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement – 07/15/2021 – 07/15/2021

On This Page Date: July 15, 2021 Time: 9:30 AM – 5:30 PM ET UPDATED INFORMATION (as of June 28, 2021): The meeting time has changed […]
July 13, 2021

January – March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity FDA is evaluating the need for regulatory action. Adlyxin (lixisenatide)Bydureon (exenatide)Bydureon BCise (exenatide)Byetta (exenatide)Ozempic (semaglutide)Rybelsus (semaglutide)Saxenda (liraglutide)Soliqua (insulin glargine and lixisenatide)Trulicity (dulaglutide)Victoza […]
July 13, 2021

2021_07 Test Article FT 01

Test one two three four five six seven eight.  Nine ten eleven. Content current as of: 07/12/2021 Regulated Product(s) Topic(s) Health Topic(s) Law(s) & Regulation(s)
July 12, 2021

FDA approves asparaginase erwinia chrysanthemi (recombinant) for leukemia and lymphoma

On June 30, 2021, the Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)-rywn) (Rylaze, Jazz Pharmaceuticals, Inc.) as a component of a multi-agent chemotherapeutic regimen […]
July 12, 2021

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

On July 9, 2021, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) in combination with pomalidomide and dexamethasone for adult […]
July 12, 2021

FDA to Discuss COVID-19’s Impact on Medical Product Operations at SBIA REdI Annual Conference

Image By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs  In the face of the COVID-19 pandemic, the U.S. Food and Drug Administration has worked […]
July 9, 2021

FDA grants regular approval to enfortumab vedotin-ejfv for locally advanced or metastatic urothelial cancer

On July 9, 2021, the Food and Drug Administration approved enfortumab vedotin-ejfv (Padcev, Astellas Pharma US, Inc.), a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult […]
July 9, 2021

FDA Approves Drug to Reduce Risk of Serious Kidney and Heart Complications in Adults with Chronic Kidney Disease Associated with Type 2 Diabetes

FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in […]
July 9, 2021

Public Notification: X Rated Honey For Men contains hidden drug ingredient

[7-9-2021] The Food and Drug Administration is advising consumers not to purchase or use X Rated Honey For Men, a product promoted and sold for sexual […]
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