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The FDA Has It Right With Drug Approvals
While keeping pace with the 2014 rate, the FDA is steaming ahead with approvals for a several breakthrough molecules. Everyone is not happy though, especially the payers who are looking at the $100,000 price tag on some of the specialty medications.
More new drugs are getting the green light in the U.S. as drugmakers take advantage of a speedier metabolism at the FDA.
Through March 19, the FDA has approved 10 new drugs, on pace to match last year’s total of 41, which was an 18-year high. The agency is moving faster partly because of 2012 mandates from Congress, analysts and industry executives say. That is spreading investor and drugmaker optimism by boosting innovative drugs that promise the biggest benefit.
This year’s approvals include the first medicine in years for initial treatment of a common form of advanced breast cancer. On March 15, researchers published data showing 2 medications that could hit the market this summer may cut heart attacks and other cardiac events in half for patients with high cholesterol.
Read the complete article on Bloomberg:
Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Trastuzumab Deruxtecan Receives FDA Approval for HER2-Positive Solid Tumors
April 5th 2024FDA granted accelerated approval to trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.
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