While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...

The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI ...

While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple ...

Since Elevidys' accelerated approval in 2023, experts have been clamoring for more data, particularly in older and ...

Lilly will use Rznomics’ proprietary ribozyme technology to develop RNA editing therapies for congenital hearing loss.

The star of the acquisition is the enzyme replacement therapy INZ-701, being developed for the rare disease ENPP1 deficiency.

Over Lars Fruergaard Jørgensen's eight years as CEO, Novo’s sales, profits and share price have almost tripled, the company ...

It's another wild twist in the story of Galapagos, a company that has been around for more than 25 years but has yet to get a ...

The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are ...

The commitment is part of Roche’s recently announced $50 billion investment in the U.S., but a company spokesperson said that ...

As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that ...

Sanofi expects to add “a significant number of high-paying jobs” in the U.S. with $20 billion investment through 2030.