Phase III
GSKs Blenrep misses the mark in the Phase III DREAMM-3 trial for relapsed or refractory multiple myeloma (RRMM), possibly putting the drug’s continued approval at risk.
Eli Lilly’s and Boehringer’s Jardiance met its primary outcome in the Phase III EMPA-KIDNEY study, the largest and broadest SGLT2 inhibitor trial in chronic kidney disease.
Sanofi and AstraZeneca won European approval for the first preventative RSV treatment for a broad population of newborns and infants.
Arcus Biosciences and its collaboration partner Gilead Sciences announced during Arcus’ third-quarter report that the company had modified its ARC-10 Phase III trial.
Apellis is submitting additional 24-month efficacy data to supplement the NDA for its intravitreal candidate pegcetacoplan for GA secondary to AMD.
Genentech made approximately 35 presentations at ECTRIMS involving blockbuster MS drug Ocrevus drug, with a focus on relapsing-remitting MS and continuing safety studies.
Abeona Therapeutics will head to the FDA next year for the potential approval of its experimental recessive dystrophic epidermolysis bullosa (RDEB) therapy following positive Phase III data.
Emalex Biosciences closed a Series D funding round Thursday counting $250 million in earnings, much of which will bankroll a Phase III trial of ecopipam for Tourette syndrome.
In a Phase III trial, Pfizer’s RSVpreF, a bivalent RSV vaccine, protected infants against severe medically attended lower respiratory tract illness when administered during the second or third trimester.
On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.
PRESS RELEASES