Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Varegacestat, a gamma secretase inhibitor, significantly improved progression-free survival while also meeting all key ...

Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in ...

The FDA had previously turned back the heart rhythm nasal spray twice, once in late 2023 with a refusal to file letter and ...

Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s ...

For $950 million upfront, Sobi will gain ownership to pozdeutinurad, an oral URAT1 inhibitor that performed well in Phase II ...

Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the ...

The FDA's Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, ...

In the midst of regulatory and political upheaval, biopharma’s R&D engine kept running, churning out highs and lows in equal ...

Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant ...

As clinical research evolves, disruptive trial designs are reshaping how oncology advances. By integrating novel ...

Every year in biopharma brings its share of grueling defeats, and 2025 was no different, especially for companies targeting ...