FDA
Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.
FEATURED STORIES
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.
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The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America’s oral alternative to its own treatment for amyotrophic lateral sclerosis (ALS).
Stealth BioTherapeutics has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elamipretide.
The FDA has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant, setting a precedent for upcoming COVID-19 treatments.
Orion announced that it will be focusing on pain and oncology going forward. As a result, 32 working professionals within the company will be terminated, although six of those will be offered different positions.
LogicBio Therapeutics has received the green light to continue dosing participants in its Phase I/II Sunrise trial, following a clinical hold placed by the FDA due to adverse events in pediatric patients.
May has been fruitful for research into the prevention and diagnosis of Alzheimer’s disease, the mechanisms behind early symptoms and potential treatments.
The FDA has extended the review period for Myfembree, following the supplemental New Drug Application from Pfizer and Myovant. Here’s more about this news.
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval for an earlier form of breast cancer from the U.S. Food and Drug Administration.
Two biologic therapeutic candidates have met their primary endpoints in phase III trials, including AstraZeneca’s Champion-NMOSD trial and Argenx’s Advance trial.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.