The FDA said data for PTC's drug did not prove "substantial evidence of efficacy." Elsewhere, the FDA delayed its decision on ...

The company’s market value was nearly cut in half following trial results showing higher rates of treatment discontinuations ...

On an earnings call, CSL CEO Paul McKenzie described weakness in the U.S. market for seasonal flu vaccines as “disappointing” ...

Tough times in the industry are forcing changes in investment and governance that should result in a healthier sector, the ...

The FDA clearance sets Novo’s medicine up a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.

Scientists say HHS’ decision to defund mRNA vaccine research will leave the country less prepared for pandemics, and make it ...

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

While Vor provided no details on the results, the company is now evaluating a global trial of the drug in the chronic immune ...

The FDA’s announcement of Papzimeos’ approval contained an unusual quote from newly reinstated CBER director Vinay Prasad. Elsewhere, Eli Lilly and Superluminal Medicines struck a deal.

The drug, which functions similar to psilocybin, scored positive enough results in a mid-stage study that Reunion is now ...

The oncology patent cliff presents a complex and urgent challenge. As blockbuster therapies approach loss of exclusivity, the ...

A new wave of Alzheimer’s research suggests semaglutide, widely known for diabetes and weight loss, could also slow cognitive ...