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

Kyverna plans to submit mivocabtagene autoleucel to the FDA for approval in the first half of 2026. If approved, it would be ...

Pfizer CEO Albert Bourla defended his company’s vaccine business as rhetoric from HHS Secretary Robert F. Kennedy Jr. drives ...

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

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

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

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

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 ...