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

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 ...

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 ...

Padcev, an antibody-drug conjugate which Pfizer acquired via its $43 billion Seagen deal, could help people who don’t qualify ...

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

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.

Liquidating its stake in Arrowhead helps Sarepta cover a milestone payment and secure what one analyst described as ...

The result marks the latest failure for a microbiome therapy in inflammatory bowel disease, which has long been a top target ...