As the FDA prepares for a busy Oncologic Drugs Advisory Committee next week, an agency insider told BioSpace that volunteers ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...

Vadodara: Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug ...

A low dose combination hormonal patch was found to be effective for pregnancy prevention based on results from a phase 3 study.

The FDA has cleared investigational new drug applications and handed out fast track designations. Plus, data shows promise for novel therapies in hard-to-treat cancers.

Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug ...

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

Novo Nordisk NOVO.B3.59%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...