The FDA said that the shared NDA documents did not show ample proof that bardoxolone methyl effectively slows down kidney function loss in patients with Alport syndrome.
The decision was intended to resolve the matter as swiftly as possible so that those who claimed to have been harmed by the product could receive expeditious compensation.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.
The FDA’s decision to approve Purdue’s drug Nalmefene earned mixed reactions, especially as the company is in the middle of lawsuits. Here’s what you need to know.
Adagio Therapeutics has appointed current COO David Hering as interim CEO, replacing Tillman Gerngross, Ph.D., who communicated his intention to resign in mid-February.
The DSMB endorsed the use of mRNA-1345 for the Phase III ConquerRSV study following positive preliminary Phase II data that demonstrates the vaccine’s safety profile.
Eli Lilly is investing $700 million to build a state-of-the-art facility in Boston, as part of plans to advance its RNA-based therapeutics research and development activities.
The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
Researchers found that augmenting estrogen levels in postmenopausal women who had tested positive for SARS-CoV-2 might help reduce one’s risk of death from COVID-19.
The FDA sent an email holding the planned Phase I trial for LB1901 after the first and only patient dosed was found to have low CD4+ T-cell counts in the peripheral blood.
