Preclinical
Researchers at multiple companies and institutes are doggedly pursuing clinical programs so the virus can become little more than a hindrance in the future.
Sanofi said that the phase II/III trial studying venglustat in autosomal dominant polycystic kidney disease was scrapped because it “did not meet futility criteria.”
The newly approved drug, Lybalvi, is a once-daily oral antipsychotic drug that is both a maintenance monotherapy or for the acute treatment of manic or mixed episodes.
Amgen reunites with Kyowa Kirin on the development and potential commercialization of KHK4083, an atopic dermatitis drug, which impacts nearly 30 million people worldwide.
The FDA gave the green light to Amgen’s Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
The U.S. FDA has granted approval to MYFEMBREE, Myovant Sciences, and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
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