FDA
The FDA’s user free programs account for just under half of the agency’s budget—money that could be imperiled by the recent staffing exodus.
FEATURED STORIES
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
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The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
Congress did not reauthorize the rare pediatric disease priority review program at the end of 2024. Advocates say the ripple effect is already being felt across biopharma.
The approval for the first-line treatment of esophageal squamous cell carcinoma comes shortly after a label expansion for the drug in gastric and gastroesophageal cancers as BeiGene also pushes forward a pipeline of novel cancer therapies.
TNKase is the first stroke drug to win FDA approval in nearly three decades.
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate an evolving mindset toward treating obesity as a chronic disease.
In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with meetings regarding vaccines and rare diseases canceled or indefinitely postponed—all without a clear reason why.
ITF, IntraBio and Orchard are among the companies that have won FDA nods in the past year for Duchenne muscular dystrophy, Niemann-Pick disease type C, metachromatic leukodystrophy and more.
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
Ctexli’s approval further entrenches Mirum as a leader in rare liver diseases, alongside its cornerstone product Livmarli and upcoming drug volixibat.
Many of these unlawful and unauthorized shipments were explicitly tagged for compounding, according to a new analysis. Separately, a group of state attorneys general has raised concerns about the unsafe GLP-1 drugs finding their way to American consumers.