The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

The U.S. Food and Drug Administration (FDA) has signed off on the first-ever cream specifically approved for treating chronic ...

Zydus Lifesciences gains FDA tentative approval for generic ibrutinib, enhancing access to vital cancer treatment for ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

The Food and Drug Administration is reconsidering its decision not to approve a drug that an Omaha mom says is saving her son ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

LEO Pharma’s Anzupgo (delgocitinib) cream has been approved by the US Food and Drug Administration (FDA) to treat adults with ...

The FDA approved Anzupgo for the treatment of moderate to severe chronic hand eczema in adults who do not adequately respond to or cannot receive topical corticosteroids, Leo Pharma announced in a ...

Positive topline results of the LunAIRo trial put AD109 on track for approval as the first oral sleep apnoea medication.