Approvals
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.
The FDA has approved two of Phathom Pharmaceuticals’ products for bacterial illnesses in adults: Voquezna Triple Pak and Voquezna Dual Pak.
PRESS RELEASES