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FDA approves an Eli Lilly NDA for Zepbound (tirzepatide) subcutaneous injection for chronic weight management in obese adults who ...[ Price : $8.95]
CBER director Peter Marks and three medical center researchers editorialize on the value of registries to promote convalescent pla...[ Price : $8.95]
Organon says it agrees with an FDA policy change to have a biosimilar statement accompany both biosimilars and interchangeables.[ Price : $8.95]
Reps. Marie Gluesenkamp Perez (D-WA), Sean Casten (D-IL), and Gerry Connolly (D-VA) introduce a bill to ban brand companies from e...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Real-Time Oncology Review (RTOR).[ Price : $8.95]
FDA releases the form FDA-483 with 14 observations from an inspection at the Kilitch Healthcare India sterile drug manufacturing f...[ Price : $8.95]
Federal Register notice: FDA proposes to withdraw approval of Phibro Animal Healths NADAs for carbadox in medicated swine feed.[ Price : $8.95]
The International Society for Cell & Gene Therapy suggests ways to improve an FDA draft guidance on manufacturing changes and comp...