The agency zeroed in on claims that compounded GLP-1 drugs are comparable to approved medicines. Elsewhere, a blood pressure drug topped Wall Street expectations and a Merck deal paid dividends.

A month after Amgen gave up on rocatinlimab — which was once seen as a threat to Dupixent — new findings have linked the drug ...

The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months ...

Cell therapy manufacturing is uniquely vulnerable to contamination, variability, and operational burden because the product - ...

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for ...

In his lengthy address Tuesday night, the president touted his efforts to make drugs and insurance more affordable but ...

Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo.

Ingram, who steered the company through multiple drug approvals and controversies, will step aside as Sarepta faces dwindling ...

Ebvallo is one of a series of rare disease treatments recently turned back by the FDA amid shifting guidance that has ...

Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but ...

Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared ...

Boehringer’s lung cancer medicine Hernexeos is the second “national priority” voucher winner to gain a speedy approval.