FDA
A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
FEATURED STORIES
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The FDA approved Wakix for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.
TB Alliance became the first nonprofit organization to win regulatory approval from the U.S. Food and Drug Administration for a new drug aimed at treating some of the most drug-resistant forms of tuberculosis.
Merck’s Keytruda has become one of the best-selling drugs in the world. Last year, it generated more than $7 billion in revenue for Merck and that is only predicted to grow, particularly as the drug wins approval for new indications.
Today it was announced that the U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ prefilled syringes for Eylea.
Waylivra was rejected by the FDA last year but gained approval in Europe in May. The publication of final Phase III data in the New England Journal of Medicine could support a potential bid for regulatory approval in the U.S.
The approval is for only “select” patients where surgery isn’t an option. It also comes with a Boxed Warning for liver toxicity, which has been a problem in several clinical trials with the drug.
The U.S. Food and Drug Administration approved Bayer’s Nubeqa (darolutamide) for non-metastatic castration-resistant prostate cancer.
The U.S. Food and Drug Administration approved the anti-PD-1 therapy as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy.
It is the first and only nasally-dosed glucagon, which is indicated for diabetic patients undergoing a severe drop in blood sugar. Previously it was only administered by a complicated injection system.
It is approved for adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.