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

The study result is the latest step forward for a drug Bristol could eventually pay more than $8 billion for and has ...

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

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.

Investors were looking for a greater difference between Ocular’s experimental medicine and a low-dose version of Eylea, ...

The lawsuit seeks to reverse the abrupt overhaul of the U.S. immunization schedule as well as the federal government’s allegedly “unlawful” reformation of a key vaccine panel.

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

Boehringer’s lung cancer medicine Hernexeos is the second “national priority” voucher winner to gain a speedy approval. Elsewhere, a landmark gene therapy was withdrawn and a Pfizer deal paid ...

Four months after Avidity’s $11.4 billion buyout, Atrium debuted with $270 million in cash and plans to pick up its ...

Wegovy and Ozempic’s list prices will be reduced by as much as 50% effective next year. Elsewhere, Palvella’s market value surged past $1 billion while Pfizer nabbed rights to another obesity drug.

The new duties will go into effect Feb. 24, although the president has since signaled he will raise the rate to 15%.

As the CGT market evolves, developers must answer one key question that will shape their manufacturing strategy: “Should we go with a modular platform or a fully integrated system?”  Both approaches ...