Approvals

Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.
FDA
The FDA approved Novo Nordisk’s Rybelsus as a first-line treatment option for adults with type 2 diabetes, signaling a shift from its previous indication as a second-line approach.
FDA
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
Lexicon Pharmaceuticals’ LX9211 fell short of its primary efficacy endpoint, according to topline data from the Phase II RELIEF-PHN-1 study in post-herpetic neuralgia.
FDA
The FDA’s top five approvals in 2022 represent an eclectic mix of cancer, cardiovascular and rare disease drugs.
Madrigal’s NASH drug hits the mark in late-stage trial.
FDA
BioCryst Pharmaceuticals is discontinuing the development of its Factor D inhibitor BCX9930 in paroxysmal nocturnal hemoglobinuria due to competitive factors.
FDA
Mirati gets the green light from the FDA for its KRAS G12C-mutated lung cancer medication.
FDA
In the heated race for a new respiratory syncytial virus vaccine for older adults, Pfizer gained ground on GSK after winning priority review designation for its vaccine candidate.
The FDA has approved Rigel’s Rezlidhia for the treatment of adults with relapsed or refractory AML with a susceptible isocitrate dehydrogenase-1 mutation.
PRESS RELEASES