The FDA gave accelerated approval for a groundbreaking drug that helps treat Hunter syndrome, a rare disease that affects ...

Experts discuss the FDA's Accelerated Approval Program, emphasizing its role in providing earlier access to innovative cancer therapies for patients. This episode focuses on the strategies for ...

Tividenofusp alfa is the first approved treatment for neurologic complications of Hunter s ...

Shares of Agios Pharmaceuticals AGIO rallied 14% on Tuesday after the company announced its intention to seek accelerated ...

The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives?

Please provide your email address to receive an email when new articles are posted on . Most oncology drugs that received FDA accelerated approval between 2011 and 2020 required postmarketing safety ...

FDA feedback enables Corbus to proceed with proposed registrational study design and endpoints to support potential ...

NovaBridge Biosciences remains a high-risk, catalyst-driven biotech, trading near cash value with a focus on pipeline ...

Upon approval, Rocket has been awarded a priority review voucher, which currently fetch around $200m on the secondary market.

In patients naïve to HER2-targeted therapy, the objective response rate was 71% with a median duration of response of 9.2 months. The Food and Drug Administration (FDA) has granted accelerated ...

In the phase 3 PEACE trial, pegzilarginase significantly reduced plasma arginine levels compared with placebo at 24 weeks, with 90% of patients in the treatment arm achieving target arginine levels.

The FDA proposes MRD negativity as an accelerated approval end point to speed access to novel myeloma therapies.