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

The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...

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

Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II ...

The mind-expanding drugs may help heal many mental health conditions. But studies haven’t actually proved that yet.

FDA extends Blenrep combo review to October to assess more data from Phase 3 trials in relapsed or refractory multiple myeloma.

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

An FDA panel meeting featured a heated dialogue over whether fluoride supplements could pose health risks to children. Here's ...