The biotech, which has a deal with Eli Lilly worth as much as $1.1 billion, is developing two targeted radiopharmaceuticals ...

These deals radically reshaped the biopharma world, either by one vaccine rival absorbing another, a Big Pharma doubling down ...

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

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

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

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

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 ...

Despite falling short of its primary Phase II objective, Nektar plans to push its T cell stimulator rezpeg into Phase III ...

Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.

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