Pharmacovigilance evolves with technology, employing active surveillance to detect drug-related issues and ensure safety in an increasingly complex landscape.

Concern is growing among public health experts that anti-vaccine sentiments within federal and state governments may derail ...

Ensuring timely completion of post-approval studies and enforcing appropriate regulatory actions based on negative trial results is necessary to minimize patient exposure to ineffective and ...

Shuren, who retired from his spot leading the FDA’s Center for Devices and Radiological Health (CDRH) in 2024, said last week ...

The review comes weeks after the Trump administration formally listed eight Latin American cartels — including six from Mexico — as Foreign Terrorist Organizations for their involvement in drug ...

The decision had been expected by April 1, but the agency now says it needs more information before moving forward.

The Food and Drug Administration (FDA) has granted accelerated approval to Vanrafia ® (atrasentan) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid ...

Adverse events from disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis decline by as much as 25% after the drugs are established on the market, according to data published ...

Pluvicto, a prostate cancer drug, has gained expanded approval that triples the number of patients with metastatic disease ...

Inebilizumab-cdon was previously approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD) in adults who are ...

The FDA is expected to decide on treatments for COPD, psoriasis, rare neuroendocrine tumors, and a next-generation COVID-19 vaccine.

Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...