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 ...

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

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 ...

Apellis Pharma (APLS) stock in focus as the FDA expands the label for its injectable therapy Empaveli to treat rare kidney ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

An epidemic that's been sustained for 44 years might finally be quelled, with the milestone approval of the first HIV drug ...

Food dyes are known to have a wide range of impacts on health, such as cancer risks, behavioral problems in children, and ...