Oligonucleotide (oligo) therapies have been in development for decades. Recent advances in molecular design, chemistry, ...

The FDA has doled out two manufacturing-related complete response letters (CRLs), slamming the brakes on prospective ...

FDA Issued Complete Response Letter Citing Outstanding Items Related to Chemistry, Manufacturing, and Controls and Non-Clinical Information FDA Does not Request Additional Clinical Data Company Intend ...

Brian Tyler remembers being in a hospital bed when the music for “The Super Mario Galaxy Movie” came to him. While in his ...

Grace was seeking FDA approval for GTx-104 in the treatment of patients with aneurysmal subarachnoid hemorrhage. ・However, the FDA issued a letter to it on Thursday, citing issues in the Chemistry, ...

Five months after Dr. Sandra Lee—best known as Dr. Pimple Popper—suffered a stroke, the surgeon detailed her road to recovery ...

Stacey Doranski suffered a medical emergency on Christmas Eve 2025. A 911 call saved her and her baby's life—and she's so ...