Approvals
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.
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Orphalan announced the FDA has granted full approval to Cuvrior (trientine tetrahydrochloride) for the treatment of Wilson’s Disease, a rare genetic disorder.
Hutchmed failed to secure FDA approval for its proposed drug for pancreatic cancer. The company will have to go through another trial if they want U.S. approval.
PRESS RELEASES