Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the ...

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

The US Food and Drug Administration (FDA) has accepted BioCryst Pharmaceuticals’ new drug application (NDA) for Orladeyo ...

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

Merck (MRK) stock in focus as the FDA approves its anticancer agent Welireg for two rare neuroendocrine tumors, expanding its ...

Montana just passed a new bill backed by longevity enthusiasts that will enable access to drugs and therapies that are not ...

MPox is endemic in DRC, and has continued to cause large numbers of cases in the WHO African Region. In April, 2025, the WHO has restated that MPox continues to be a Public Health Emergency of ...

Cytokinetics' PDUFA date for aficamten was extended to December 26th of 2025, due to the FDA's need to review a submitted ...

There could be an upside to incorporating AI for the FDA. Using AI to assist in final drug reviews would "represent a chance ...

Quantum Biopharma plans to file an application by year's end seeking FDA clearance for a Phase 2 clinical trial testing Lucid ...

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development.

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