Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s ...
The FDA had previously turned back the heart rhythm nasal spray twice, once in late 2023 with a refusal to file letter and ...
Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in ...
Varegacestat, a gamma secretase inhibitor, significantly improved progression-free survival while also meeting all key ...
Sanofi’s multiple sclerosis hopeful tolebrutinib faced dual setbacks on Monday, with a late-stage failure in one form of the ...
For $950 million upfront, Sobi will gain ownership to pozdeutinurad, an oral URAT1 inhibitor that performed well in Phase II ...
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 ...
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 ...
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant ...
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former ...
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