FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs.

FDA updates blood donation guidelines to try and increase number of donors ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Scientists at The Wistar Institute have discovered that a class of FDA-approved cancer drugs known as PARP1 inhibitors can ...

A study published in the Journal of Medical Toxicology by researchers at the University of Alabama at Birmingham found that ...

FDA researchers report that the upper end of reported consumer use (~400mg of daily CBD intake) of cannabidiol (CBD) may ...

Received FDA approval of EKTERLY® (sebetralstat)-the first and only oral on-demand treatment for hereditary angioedema; U.S. launch underway - - Six additional global regulatory submissions under ...

I think the commission and the staff are more encouraged than we have been any time in the past to date.” By Alander Rocha, ...

Cardiac amyloidosis is an often-missed, life-threatening cause of heart failure. As new disease-modifying therapies emerge, ...

H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health ...

There are many obstacles ahead, including ongoing legal battles and strong opinions regarding the program’s structure and ...