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May 27, 2026
The FDA extended the review deadline for AstraZeneca's camizestrant and issued a complete response letter for its COPD drug PT010. The agency also adopted a single-pivotal-trial approval policy, while AstraZeneca sold Losec rights to Cheplapharm.
May 19, 2026
The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.
Apr 03, 2026
The ASCENT-04 trial shows Trodelvy plus Keytruda extends progression-free survival by 3.4 months in PD-L1-positive metastatic triple-negative breast cancer. Meanwhile, the ToPCourT trial investigates trilaciclib combined with pembrolizumab and chemotherapy for advanced TNBC. These developments signal evolving treatment approaches for this aggressive breast cancer subtype.
Mar 10, 2026
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
