FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.
FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, including when the agency mi...
FDAs approval of Outlook Therapeutics Lytenava shows that the agencys willingness to accept one adequate and well-controlled trial plus confirmatory e...
AstraZeneca and Daiichi Sankyo says that Enhertu cut the risk of disease progression or death by 37% compared with pembrolizumab (Mercks Keytruda) plu...
AstraZeneca says that its Etcamah (camizestrant) failed to significantly improve progression-free survival in the Phase 3 SERENA-4 trial testing the o...
Saint Louis University law professor Michael S. Sinha says FDAs next commissioner should focus on rebuilding the agencys depleted workforce, restoring...
FDA extends by three months its review of an Exelixis NDA for zanzalintinib, in combination with atezolizumab, for treating patients with metastatic c...
Oncology Center of Excellence director Angelo de Claro says the center will build on initiatives established under longtime and former OCE chief Richa...
