The agency acted after reviewing mouse data submitted in 2024, making the timing of the new pause “confusing,” one analyst wrote.

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.

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.

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

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

Atavistik Bio is using the cash to develop “allosteric” medicines it believes can precisely impact on diseases like myelofibrosis and the blood condition HHT.

A service tailored to people with workplace-based insurance coverage represents a new way for Lilly to bypass insurers and expand use of its popular obesity shot.

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

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

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

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

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