FDA Embraces A New Review Process And Approves SNM's Multi-Center IND For FLT (Medical News Today)
SNM has announced FDA approval of an SNM-sponsored centralized multi-center investigational new drug (IND) application for 18F-labeled 3'-deoxy-3'-fluorothymidine (FLT). The approval of multi-center Chemistry Manufacturing and Controls (CMC) in the FLT IND represents the successful demonstration of an important FDA IND review process for positron emission tomography (PET) imaging biomarkers.

FDA Approves KAPIDEX (dexlansoprazole) Delayed-Release Capsules For The Treatment Of GERD (Medical News Today)
Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S.