From Indiana to Iceland, the FDA this week disclosed concerns raised during recent visits to a pair of manufacturing sites ...

With two approved medicines to treat primary immunoglobulin A nephropathy (IgAN) and a third therapy in phase 3 testing, ...

The transaction's two focuses, Palsonify and atumelnant, have combined peak sales potential of more than $5 billion, Vertex ...

As Pfizer and Moderna have tied off certain threads in their separate webs of mRNA patent litigation, Sanofi has opened a new ...

In Novo Nordisk and Eli Lilly’s competition to launch their respective GLP-1 obesity pills in the United States, the Danish ...

In an initiative to increase the efficiency of drug manufacturing in the United States, the FDA has proposed a streamlined ...

A bipartisan bill reintroduced by three senators aims to increase transparency around foreign influence on the United States’ ...

After speedrunning a series of major manufacturing milestones in the past year and a half, the “biotech floodgates” have ...

Red-hot generative AI specialist Insilico Medicine has teamed up with another major biopharma player, this time linking up ...

Zhejiang Huahai Pharmaceutical has hired a former FDA staffer as its new chief quality officer, as the company struggles to resolve compliance issues with the FDA at a key manufacturing facility.

Merck & Co.’s almighty Keytruda has become the first PD-1 inhibitor to show a benefit as a single agent for the front-line treatment of a subtype of endometrial cancer. | Merck & Co.’s almighty ...

The comment-seeking period and probe tie back to Sanofi’s marketing for its flu shot for adults ages 60 and over, which is ...