Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced that the U.S. Food and Drug Administration has granted Fast ...

First of many planned label expansions supporting Vision 2030 goal to become the leading endocrinology rare disease companyOn track to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...

Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading ...

These two clearances mark an important step forward for Bioventus and represent a substantial growth opportunity as the Company looks to expand in the PNS market, which is currently estimated to be ...

In a breakthrough for cardiovascular medicine, researchers have harnessed artificial intelligence to discover unexpected ...

FDA Commissioner Marty Makary said the FDA’s review process will not slow down despite layoffs at the Department of Health ...

Dr. Vinay Prasad is stepping down as the Food and Drug Administration's top vaccine regulator after a brief tenure.

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

Gas station heroin” took another hit on Wednesday as HHS Secretary Robert F. Kennedy Jr’s FDA recommended a scheduling action ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...

The U.S. Food and Drug Administration's top vaccine official, Vinay Prasad, has left the agency after just three months as ...