Phase III
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.
Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.
An investigator in the Phase III trial for Biogen and Eisai’s experimental Alzhiemer’s drug, lecanemab, is attributing a patient’s death to the treatment.
GSK is pulling the plug on an experimental monoclonal antibody therapy for rheumatoid arthritis following a significant miss in one of three Phase III trials.
The FDA has upheld the accelerated approval of Jazz Pharmaceuticals’ Zepzelca (lurbinectedin), even though the drug failed to reach its primary endpoint in the confirmatory Phase III ATLANTIS trial.
PRESS RELEASES