Phase III
Topline data from the Phase III NATALEE study showed Novartis’ Kisqali met its primary endpoint, reducing the risk of recurrence in early breast cancer.
The FDA approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta syndrome, the company announced Friday.
The FDA has granted an advisory committee meeting for BrainStorm Cell Therapeutics’ investigational ALS therapy, NurOwn, the company announced Monday.
Relmada Therapeutics announced it would make key changes to its clinical evaluation of REL-1017 as a possible add-on treatment for major depressive disorder.
Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna’s stock following the data reveal.
In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.
Sanofi and Regeneron’s Dupixent (dupilumab) met its primary and all secondary endpoints in the Phase III BOREAS trial, significantly reducing severe exacerbations in COPD.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9-0 that tofersen’s effect on neurofilament light chain (NfL) could be a reasonable predictor of clinical benefit.
Yescarta is the first treatment in nearly 30 years to improve overall survival in relapsed/refractory large B-cell lymphoma R/R LBCL, according to Gilead’s Kite Pharma.
Following recent meetings with the FDA and European Medicines Agency, Mereo Biopharma is designing a Phase III study of alvelestat to treat alpha-1-antitrypsin deficiency-associated lung disease.
PRESS RELEASES