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.

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

Announced days before a trial, the deal settles a longstanding dispute and avoids what one analyst called a “worst-case scenario” financially for Moderna.

Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but at the expense of higher side effect rates.

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 ...

The planned filing comes amid heightened scrutiny of the FDA’s rare disease stance and a year after Prime deprioritized the program for economic reasons.

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

The deal adds to a growing biotech presence for Blackstone and supports testing of a drug competing with rival therapies from Merck and Roche.

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

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

According to one analyst, the alliance and early data “validate” the oncology work of Vir, which was once purely an ...