This marks the first US approval for AstraZeneca and Daiichi Sankyo's Trop-2-directed antibody drug conjugate.
The FDA also approved Qiagen's Therascreen KRAS RGQ PCR kit as a companion diagnostic to identify KRAS G12C-mutant patients.
Although Pfizer is not among the drugmakers suing the government to block negotiations, it has said the program will hinder drug R&D and innovation.
HHS is asking the court to affirm its Office of Inspector General's finding that paying for fertility services would run ...