Apellis Pharmaceuticals says it will file an NDA during the first half of 2022 for intravitreal pegcetacoplan for treating a blindness causing conditi...
A Journal of Clinical Pharmacology study finds that FDA has less oversight of overseas clinical trials that are used to form the basis of approval for...
FDA approves a PharmaEssentia BLA for Besremi injection to treat adults with polycythemia vera, a blood disease associated with red blood cell overpro...
Novavax requests a meeting with FDA in advance of filing for approval of its Covid-19 vaccine.
FDA grants PureTech Health an orphan drug designation for LYT-200 and its use in treating pancreatic cancer.
Data presented by Genentech show AC Immunes semorinemab reduced cognitive decline compared to placebo in a Phase 2 Alzheimers disease trial.
Par asks FDA not to approve an Eagle ANDA referencing Vasostrict until specified changes are made regarding the pH specification.
The Oklahoma Supreme Court says a lower court erred in determining that J&J violated the states public nuisance law in the way it marketed prescriptio...