Analysts at Jefferies called the approval "highly significant," estimating it could add $2 billion to $3 billion to peak ...

Ambros Therapeutics’ non-opioid bisphosphonate analgesic, already approved in Italy, will soon begin a pivotal test in the ...

Johnson & Johnson, which did not apply for the national priority voucher, was granted the ticket based on results from a ...

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 ...

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

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

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

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

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

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