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European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
After years of suffering from a bear market and more than 14 months of geopolitical turmoil shaking the macroenvironment, biotech appears to be moving on.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
CSL’s AEGIS-II trial and cell and gene therapy expansion highlight the significant global expansion within the company over the past five years.
The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.
Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.
Amid high rates of U.S. obesity, a bipartisan bill has been reintroduced in the Senate and House of Representatives with backing from Eli Lilly, Novo Nordisk and Boehringer Ingelheim.
The company’s sales guidance for 2023 has been raised to $98.8 billion to $99.8 billion, driven by cancer drugs and medical devices. J&J’s stock rose about 5% in early trading Thursday.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
The company is handing back a multivalent Shigella vaccine candidate to LimmaTech Biologics, which spun out in 2015 after GSK’s acquisition of GlycoVaxyn for $190 million.