Radiopharmaceutical Gets FDA Approval for Treatment of Prostate Cancer
Patients with metastatic castration-resistant prostate cancer now have a new treatment option with the U.S. Food and Drug Administration’s (FDA’s) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan). The radiopharmaceutical medication, from Novartis...
FDA Getting More Muscle to Take Unproven AA Drugs Off the Market
Created in 1982 in response to the HIV/AIDS epidemic, the U.S. Food and Drug Administration’s (FDA’s) Accelerated Approval (AA) Program provides for expedited approval of novel treatments of serious health conditions that the current market isn’t adequately serving....
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
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