FDA approves Lilly’s Verzenio as adjuvant therapy for early breast cancer
The US FDA approved Verzenio based on results from Phase 3 monarchE trial in adults with HR+ HER2-,…
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14 Oct 21
The US FDA approved Verzenio based on results from Phase 3 monarchE trial in adults with HR+ HER2-,…
14 Oct 21
The FDA approval is based on the Phase 3 KEYNOTE-826 trial, which showed superior overall survival and progression-free…
12 Oct 21
Merck’s regulatory submission for molnupiravir is based on positive results from the interim analysis of Phase 3 MOVe-OUT…
12 Oct 21
Gantenerumab is an investigational IgG1 antibody designed to block certain forms of amyloid beta and eliminate brain amyloid…
11 Oct 21
The company claims that Tavneos is the first orally-administered inhibitor of the complement 5a receptor to receive the…
06 Oct 21
The company’s submission of antibody cocktail is based on safety and efficacy data from the Phase 3 PROVENT…
05 Oct 21
The US FDA has granted BTD for Enhertu based on results from the DESTINY-Breast03 trial, in which Enhertu…
04 Oct 21
Tecartus has received breakthrough therapy designation and a priority review from the FDA and is also being evaluated…
01 Oct 21
Cibinqo was approved in Japan based on results from four Phase 3 studies in 1,513 patients, along with…
29 Sep 21
The US FDA approval is based on data from a large-scale clinical programme evaluating the efficacy, safety and…