FDA's Radiopharmaceutical Drugs Advisory Committee
Will review NDAs for two myocardial imaging agents, Squibb's Cardiotec (technetium Tc99m teboroxime) and DuPont's Cardiolite (technetium Tc99m sestamibi), at its scheduled Nov. 17 meeting in Conference Rooms G and H of FDA's Parklawn Building.
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With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.
Japan approves a batch of new products and indications, including Daiichi Sankyo's Enhertu in a high-need indication after a rapid review and Takeda's Zejula, which will be made available to selected patients before its reimbursement listing.
Public Company Edition: Outside the US, Zai Lab raised more in its recent Hong Kong initial public offering – $766.4m – than PMV, Prelude, Taysha, Graybug and Greenwich combined. Also, Gilead priced debt to fund its $21bn Immunomedics buy and ADC Therapeutics raised $204m.