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, ...
As Pfizer and Moderna have tied off certain threads in their separate webs of mRNA patent litigation, Sanofi has opened a new ...
The transaction's two focuses, Palsonify and atumelnant, have combined peak sales potential of more than $5 billion, Vertex ...
Kelun scores sac-TMT win in first-line NSCLC population missing from Merck’s massive phase 3 program
The clinical blueprint for Merck & Co.’s prized TROP2-directed antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), ...
Huyabio has scored a win in the largest oncology study it has undertaken in its 22 years, as its oral histone deacetylase ...
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 ...
The comment-seeking period and probe tie back to Sanofi’s marketing for its flu shot for adults ages 60 and over, which is ...
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