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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Seattle Genetics announced today that the FDA has granted approval for its Adcetris drug to treat Hodgkins Lymphoma.
The FDA granted a Priority Review designation to Pfizer and partner Astellas Pharma for expanded use of Xtandi in prostate cancer treatment.
On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly’s re-submission for their moderate-to-severe rheumatoid arthritis drug.
A U.S. Food and Drug Administration announced their decision to slap a clinical hold on Solid Biosciences Inc.’s experimental gene therapy treatment for Duchenne muscular dystrophy.
Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA.
The U.S. Food and Drug Administration has approved Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk.
The U.S. Food and Drug Administration (FDA) expanded the dosing schedule for Bristol-Myers Squibb’s Opdivo (nivolumab).
Shares of Prometic Life Sciences Inc. jumped this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation.