appears poised to continue with a plan to ban prescription fluoride supplements at a time when many experts say that access to the products has become especially important.

The Revell family hoped a gene therapy could buy time for their sons, who have a rare and fatal disease. After two patients ...

She struggled to sleep. Her brain felt foggy. Her doctor prescribed an antidepressant, even though the then ...

Despite regulatory setbacks, the petitioners believe that survival and other data they've collected themselves are worth ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

Institutional investors including Armistice Capital, RTW Investments, and Wellington Management have increased their exposure ...

On Nov. 26, 2019, ChemoCentryx issued a press release announcing that the Advocate trial met both of its primary endpoints, saying Tavneos showed noninferiority of disease remission at 26 weeks and ...

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular ...

The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.

The FDA may remove the warning labels on hormone replacement therapies used to treat the symptoms of menopause. Doctors say ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...