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May 15, 2026 | FDA's CDER Chief Høeg Expected to Exit; Tecentriq Wins Bladder Cancer Approval
Description
Three top FDA positions now in temporary hands as CDER's Høeg follows Makary out the door. Roche's Tecentriq wins ctDNA-guided bladder cancer approval with 36% DFS and 41% OS risk reductions paired with Natera's Signatera diagnostic. Plus Enhertu's early breast cancer expansion, Rigel's $85M Veppanu deal, Biogen's tau gamble, and oral Wegovy's first prescription decline.
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pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, CDER, Tracy Beth Høeg, Marty Makary, Richard Pazdur, Roche, Tecentriq, atezolizumab, Natera, Signatera, ctDNA, bladder cancer, Enhertu, trastuzumab deruxtecan, Daiichi Sankyo, AstraZeneca, breast cancer, HER2, Novo Nordisk, Wegovy, oral semaglutide, GLP-1, Aardvark Therapeutics, ARD-101, Prader-Willi syndrome, Rigel Pharmaceuticals, Veppanu, vepdegestrant, Arvinas, Pfizer, United Therapeutics, UHeart, xenotransplantation, Biogen, BIIB080, tau, Alzheimer's, Takeda, Create Medicines, mifepristone, SCOTUS, Lilly, Merck