The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.

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 ...

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received positive feedback from the U.S. Food and Drug Administration ...

BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India, July 15, 2025 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL) , a fully int ...

Biocon Biologics Expands Diabetes Portfolio with FDA Approval of Kirsty™, the First and Only Interchangeable Rapid-Acting Insulin Aspart in the United States ...

Bio-Techne Corporation (NASDAQ: TECH) today announced that its Simple Western Technology played a key role in supporting ...

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.

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