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

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

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

Antibody-drug conjugates from Kelun-Biotech and Hansoh Pharma, respectively partnered with Merck & Co. and GSK, delivered positive phase 3 readouts in China. AstraZeneca reached out to its spinout, ...

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

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

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

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.

Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase ...

In the second of a new series of interviews with top executives from leading healthcare and comms agencies, Fierce Pharma ...

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

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