Core Insights - AstraZeneca's Imfinzi has received European Commission approval for treating muscle-invasive bladder cancer (MIBC) in adults, marking a significant milestone for the company [1][6] - The approval is based on the phase III NIAGARA study, which demonstrated a 32% reduction in the risk of disease progression or death with the Imfinzi-based treatment regimen [2][6] - Imfinzi is a key revenue driver for AstraZeneca, generating $1.26 billion in sales in Q1 2025, reflecting a 16% year-over-year increase [6][9] Regulatory Approval - The European Medicines Agency's Committee for Medicinal Products for Human Use had previously recommended approval for Imfinzi in May, leading to the recent EU approval [3] - The FDA also approved Imfinzi for a similar indication in March, with additional regulatory applications under review in Japan and other countries [3] Clinical Study Results - The NIAGARA study showed a 25% reduction in the risk of death for patients treated with the Imfinzi-based regimen compared to the control group [2] - Imfinzi is currently approved for multiple cancer indications, including stage III non-small cell lung cancer (NSCLC) and other advanced cancers [8] Market Performance - Year-to-date, AstraZeneca's shares have increased by 6%, contrasting with a 1.4% decline in the broader industry [4] - Imfinzi's sales growth is primarily driven by demand in lung and liver cancer treatments [6][9]

Volatile biotech stock Biohaven (BHVN -19.41%) is prone to sharp movements both up and down. On Thursday, it had one of its down days, with its share price eroding by almost 20% on a development with a top regulator. That was on a day when stocks generally did well, as indicated by the S&P 500 (^GSPC 0.41%) landing in positive territory with a 0.4% rise. A regulatory extensionAfter market close on Wednesday, Biohaven divulged that the U.S. Food and Drug Administration's (FDA) Division of Neurology 1 is exte ...

金十数据5月15日讯，英国药品审批机构抵制制药公司要求其放宽药物推荐流程的压力，而是敦促英国 国家医疗服务系统（NHS）加快批准药物的推出。部长们一直在向英国国家卫生与保健研究所 （NICE）施压，要求其展示其如何提高生产率并为经济增长做出贡献。 （英国金融时报） 英国药品审批机构抵制要求放宽审批程序的压力 ...