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Results from Astellas' Pivotal Phase 3 SKYLIGHT 1™ Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet PR Newswire Treatment with fezolinetant resulted in statistically significant reductions in the frequency and severity of VMS and imp...
Astellas Announces Phase 3 China ARCHES Study of XTANDI® Meets Primary Endpoint PR Newswire XTANDI ® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT Study enrolled 180 men wi...
2023-03-13 08:07:25 ET Bristol Myers ( NYSE: BMY ), Pfizer ( NYSE: PFE ), and AbbVie ( NYSE: ABBV ) are among firms likely to face Medicare price negotiations for some of the key blockbuster medications, Reuters reported Monday, citing five Wall Street and ac...
Astellas and Seagen Announce China's National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer PR Newswire – Clinical data submitted are consistent wi...
Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib PR Newswire TOKYO and ROCKVILLE, Md. , March 9, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa , Ph.D., "Astellas") and the Bl...
2023-03-05 12:00:42 ET Cancer drugmaker Seagen ( NASDAQ: SGEN ) had reportedly drawn interest from two pharma giants in less than a year, indicating a bidding war not seen since Horizon Therapeutics ( HZNP ) sparked a buyout fight which Amgen ( AMGN ) won in late 2022. ...
Merck ( NYSE: MRK ) is discontinuing a phase 3 trial of a Keytruda combination treatment for prostate cancer after the study failed its main goals, while another late stage trial of the blockbuster drug did not meet its main objectives to treat a type of lung cancer. Prostate c...
Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease PR Newswire Data presented at the 19th Annual WORLDSymposium™ 2023 TOKYO , Feb. 22, 2023 /PRNe...
The U.S. Food and Drug Administration (FDA) extended review period by three months of Astellas Pharma's ( OTCPK:ALPMF ) ( OTCPK:ALPMY ) fezolinetant to treat moderate to severe vasomotor symptoms (VMS) due to menopause. The company said the FDA needed more time to review the new ...
Astellas Provides Update on Fezolinetant New Drug Application in U.S. PR Newswire TOKYO , Feb. 19, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa , Ph.D., "Astellas") today announced the U.S. Food and Drug Administrati...
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Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer PR Newswire - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted...
Astellas Receives Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer PR Newswire - If approved, enfortumab vedotin in combination with pembrolizumab ...
Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy PR Newswire - Collaborative Research on Innovative Cartilage Organoid Cell Therapy for In...