Yescarta became the second approved CAR T therapy in Japan, joining a basket of new approvals by the country’s Ministry of Health, Labour and Welfare. The therapy, developed by Gilead Sciences Inc. (NASDAQ:GILD) and partnered...

BioNTech prices upsized financing BioNTech SE (NASDAQ:BNTX) raised $511.5 million in an upsized offering through the sale of 5.5 million ADSs at $93 per ADS. The deal, which had been slated for 5 million ADSs,...

Bolt’s $93.5 million series C round will enable the Stanford spinout to clinically test whether its myeloid-activating antibody conjugate can provide durable treatment to a broad swath of HER2-positive solid tumor patients. Led by Sofinnova...

A recommendation by EMA’s CHMP suggests remdesivir from Gilead Sciences Inc. (NASDAQ:GILD) could soon gain a speedy conditional approval to treat COVID-19. The committee announced the decision this week along with a basket of other...

AstraZeneca stole the show at ASCO on Friday with data that should help propel its top-grossing cancer drug and one of its newest market entrants into broadly expanded patient populations, as long as physicians adopt...

Japan submission on horizon for AZ, Daiichi’s ADC Daiichi Sankyo Co. Ltd. (Tokyo:4568) plans to seek approval of Enhertu for gastric cancer starting in Japan after the anti-HER2 antibody-drug conjugate met the primary and a...

Priority Review for breast cancer ADC from Daiichi, AZ AstraZeneca plc (LSE:AZN; NYSE:AZN) and Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA accepted and granted Priority Review to a BLA for trastuzumab deruxtecan to treat HER2-positive...

FDA approves Daiichi's pexidartinib FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat tenosynovial giant cell tumor. A Daiichi spokesperson told BioCentury the drug has been launched at a wholesale acquisition cost...

Complete response letter for Daiichi's quizartinib Daiichi Sankyo Co. Ltd. (Tokyo:4568) said FDA issued a complete response letter for quizartinib, its candidate to treat relapsed/refractory FLT3-ITD-positive acute myelogenous leukemia (AML). In May, an FDA advisory...

FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib Despite both pexidartinib and quizartinib meeting the primary endpoints in their pivotal trials, FDA reviewers raised concerns about each agent from Daiichi Sankyo Co. Ltd. (Tokyo:4568) in...