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23.02.26 - 11:48
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Roche receives FDA acceptance for giredestrant combo NDA (PBR)
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The submission targets adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer that has progressed after previous endocrine-based
The post Roche receives FDA acceptance for giredestrant combo NDA appeared first on Pharmaceutical Business review....
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20.02.26 - 07:03
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FDA accepts New Drug Application for Roche′s giredestrant in ESR1-mutated, ER-positive advanced breast cancer (GlobeNewswire EN)
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Basel, 20 February 2026 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company's New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by 18 December 2026. Giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader (SERD) combination approved in the post-cyclin-dependent kinase (CDK)4/6 inhibitor setting....
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18.02.26 - 17:18
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Roche will altgedientes Antibiotikum Rocephin verkaufen (Cash)
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- Der Pharmakonzern Roche will sich vom ersten Blockbuster seiner Geschichte trennen. Der Basler Konzern sucht für sein Antibiotikum Rocephin einen Käufer. Die Produktion des Mittels am Standort Kaiseraugst soll damit am Ende des Jahrzehnts eingestellt werden....
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18.02.26 - 17:12
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Roche will altgedientes Antibiotikum Rocephin verkaufen (Cash)
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- Der Pharmakonzern Roche will sich vom ersten Blockbuster seiner Geschichte trennen. Der Basler Konzern sucht für sein Antibiotikum Rocephin einen Käufer. Die Produktion des Mittels am Standort Kaiseraugst soll damit am Ende des Jahrzehnts eingestellt werden....
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