Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Dr. Marty Makary tells CBS News' Norah O'Donnell in an exclusive interview why the agency decided to drop decades ...
UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.
WEST MICHIGAN — Menopause is the term to describe women no longer receiving natural estrogen from her ovaries, and for several years, women who would be excellent candidates for Menopause Hormone ...
In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug ...
The Food and Drug Administration is taking a closer look at kratom extracts and preparing to ask Congress for expanded authority to shut down illegal vaping imports, according to the agency’s head. In ...
In a recent interview, Food and Drug Administration Commissioner Marty Makary declared that Medicare should automatically cover FDA-designated breakthrough devices — a rare and refreshing commonsense ...
"The stories are so outrageous," Senator Ron Johnson said. "It just appears that they’re looking for excuses to say no." ...
In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...
President Trump’s Food and Drug Administration is cracking down on the “endless” barrage of pharmaceutical advertisements Americans are hit with on a daily basis, FDA Commissioner Marty Makary said on ...
A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of ...
Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.
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