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

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

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

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

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.

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 Elsewhere, a landmark gene therapy was withdrawn and a Pfizer deal paid ...

Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.

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.

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

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

Novo’s answer to a closely watched Lilly drug spurred roughly 20% weight loss after 24 weeks in a Phase 2 trial, results one of its executives claimed to be “differentiating.” ...

One of biotech’s longest-tenured leaders, Pops steered Alkermes through several reinventions, the latest of which has made it ...