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Pfizer's Talzenna Label Bid Faces Setback
FDA
The FDA’s advisory committee unanimously rejected Pfizer’s proposal to expand Talzenna’s use for prostate cancer patients without HRR mutations, citing insufficient evidence from the TALAPRO-2 trial.
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FDA Panel Supports Darzalex for Early Myeloma
Darzalex
Johnson & Johnson's Darzalex Faspro gains FDA advisory backing as a potential first treatment for high-risk smoldering multiple myeloma, despite concerns over trial design, patient selection, and long-term efficacy.
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FDA Approvals Summary - April 2025
FDA Drug Approvals
Discover the FDA's new drug approvals in April 2025, including treatments for IgAN, nasopharyngeal carcinoma, myasthenia gravis, and colorectal cancer. Learn about groundbreaking therapies like Vanrafia, Penpulimab-KCQX, and Imaavy.
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FDA Drug Rejections (January-April 2025)
FDA
From January to April 2025, the FDA rejected six new drug applications, citing issues like clinical data, CMC problems, and third-party manufacturing concerns. Learn more about each case.
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The Cost of Attacking the Pharmaceutical Industry
Trump
Trump's policies during his second term have rocked the U.S. scientific community, slashing NIH funding, threatening pharmaceutical innovation, and reshaping the global research landscape amid rising concerns about America's future in science.
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