FDA Approves First State Request to Import Drugs From Canada and 5 Upcoming FDA Approvals

New FDA Approvals

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Today’s episode: FDA approves first state request to import drugs from Canada: The FDA has approved Florida's request to import certain drugs from Canada, marking the first time a state has been authorized to buy lower-cost medications in bulk from abroad.https://www.cnn.com/2024/01/05/politics/florida-canada-drug-imports-fda/index.html https://www.flgov.com/2024/01/05/florida-becomes-first-in-the-nation-to-have-canadian-drug-importation-program-approved-by-fda/

· 5 FDA decisions to watch for:

o Donanemab from Eli Lilly, if approved, could be a significant Alzheimer's treatment, with Phase 3 trial results showing substantial cognitive and functional decline slowing.

o Resmetirom, an oral thyroid hormone receptor agonist, manufactured by Madrigal Pharmaceuticals showed promise in addressing nonalcoholic steatohepatitis (NASH), a leading cause of liver transplantation.

o Sotatercept, acquired by Merck, is being evaluated for treating pulmonary arterial hypertension (PAH) based on promising results from the Phase 3 STELLAR trial.

o Lifileucel, in a phase 3 trial for melanoma, is the first tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma. FDA's decision on lifileucel is expected by mid-February, and it offers potential as a one-time cell therapy for solid tumor cancer.

o Odronextamab, developed by Regeneron Pharmaceuticals, could become the first bispecific antibody approved for both FL and DLBCL, common non-Hodgkin lymphoma subtypes.

This content was independently written by Dr. Emma Hitt Nichols, but the idea for the 5 upcoming drugs came from this article https://www.biopharmadive.com/news/5-fda-approval-decisions-watch-first-quarter-2024/703377 Use Your Scientific or Medical Background in Medical Editing & Factchecking so you can supplement your income while working from anywhere on your own schedule. Visit learnAMAstyle.com for a free step-by-step checklist.

Get immediate medical writing assistance from experienced, excellent, native-English speaking MD- and PhD-medical writers. Nascentmc.com