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The FDA has rejected Repros Therapeutics’ NDA for its secondary hypogonadism treatment enclomiphene, asking the drugmaker to conduct an additional Phase 3 study or studies, as the original trials are no longer adequate to demonstrate clinical benefit. Read More
Eli Lilly scored an FDA approval Tuesday for EGFR inhibitor Portrazza in combination with chemotherapy for second-line treatment in metastatic squamous non-small cell lung cancer. Read More