After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...

The US Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza, a subcutaneous anti-PD-(L)1 cancer ...

The FDA should be more open and collaborative to unleash a surge in approvals of rare disease drugs, according to a report by ...

Clinical laboratory lobbying groups are suing the FDA over its plans to more strictly regulate lab-developed tests. For now, ...

Indies Pharma Jamaica Limited has made history as it became the first Jamaican company to get an ANDA (Abbreviated New Drug ...

The regulatory approval is just the first phase of a long project, but Neuralink owner Elon Musk is already touting his brain ...

For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory ...

Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes ...

Calley Means, co-founder of TruMed, recently raised concerns about conflicts of interest within the FDA and the influence of ...

Hoping to skirt the slow pace of new drug development, researchers are leaning on AI to uncover fresh uses for known ...

Elon Musk's brain-chip startup has just received its first big win, the breakthrough device, experimental implant, Blindsight ...

The nasal spray option could encourage more people who have fears of doctors or needles to inoculate themselves against the ...