FDA reverses decision not to review Moderna’s new flu vaccine ... An estimated 30 million Americans have one or more rare disorders, 95% of which have no FDA-approved treatment ... The FDA told Moderna it was OK with its clinical trial design.
FDA has placed partial clinical hold on LINNET study of lorigerlimab in gynecologic cancer ... Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDA.
Regulatory Shift Could Significantly Lower Phase 3 Costs and AcceleratePathTowardNDASubmission for AD04. Regulatory Shift Could Significantly Lower Phase 3 Costs and Accelerate Path Toward NDA Submission for AD04 ... .
Artios receives FDAFast Track designation for DNA polymerase theta (Polθ) inhibitor ART6043 for treatment of gBRCA-mutated HER2-negative breast cancer ... .