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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Shares of Eli Lilly jumped in premarket trading after the company reported total revenue of $6.35 billion for the second quarter, a 9 percent increase in revenue over the same period last year.
Shares of Agios Pharmaceuticals jumped this morning after the company said the FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year.
The U.S. Food and Drug Administration is looking to address supply chain threats by potentially importing foreign drugs under a narrow scope.
In a speech given at the Brookings Institution preceding the release of the U.S. Food and Drug Administration (FDA)’s Biosimilars Action Plan, FDA Commissioner Scott Gottlieb unloaded on big pharma.
In 2012, the U.S. Food and Drug Administration (FDA) created Breakthrough Therapy designation. The Washington Post reports on a new study conducted by Yale School of Medicine researchers and published in the Journal of the American Medical Association that looks at the designation and the drugs that received it.
HIV patients have some good news this morning. The U.S. Food and Drug Administration approved Janssen Pharmaceutical’s Symtuza, the first and only complete darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1).
Four months after filing a supplemental New Drug Application with the U.S. Food and Drug Administration, Astellas and Pfizer snagged regulatory approval for Xtandi as a treatment for non-metastatic Castration-Resistant Prostate Cancer (CRPC).
The U.S. Food and Drug Administration (FDA) was busy during the first half of this year with more than 20 novel drug approvals. Of those approvals, one-third came in June.
Shares of Siga Technologies soared more than 11 percent late Friday after the company announced that its smallpox treatment Tpoxx was approved by the U.S. Food and Drug Administration.
July can be a notoriously slow period for FDA activity, and this year is no different. There are only five PDUFA dates scheduled for the month, and the first one was a supplemental approval for Merck’s Keytruda. The PDUFA date was July 3, but it was approved June 13. At this point in the month there are only four more approvals on the docket, here are the remaining approvals scheduled for July.