FDA
The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Voucher but after a shortened review time has decided the data did not support regulatory approval for treating erythropoietic protoporphyria.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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Yet another busy week for clinical trial news. Here’s a look.
Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
Emergent BioSolutions, the manufacturer responsible for the doses in question, is reportedly just waiting for the U.S. FDA’s signal to start shipping the vaccines.
The letter was related to a 2021 FDA inspection connected to Sesen’s Biologics License Application for Vicineum. Read more about this sesen bio news here.
A large number of people were waiting for the breast cancer vaccine. Now, at present, the world has witnessed the first potential vaccine. Let’s take a look at it.
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
Xipere was approved for suprachoroidal use for the macular edema treatment. Macular edema is associated with uveitis, it is a form of eye inflammation.
The U.S. FDA has a busy period at the end of October heading into the first week of November.
Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.