Phase III
The company said the study demonstrated broad efficacy, showing statistically significant superiority to placebo over a total of 15 prespecified primary and secondary outcome measures.
Austin, Texas-based Aeglea Biotherapeutics reported what initially appears to be positive outcomes for its Phase III PEACE trial of pegzilarginase in Arginase 1 Deficiency (ARG1-D).
The latest updates from Mesoblast Limited’s Phase III trial on rexlemestrocel-L show that the drug provides the highest benefit when used in patients with certain types of chronic heart failure.
The approval of Keytruda also now includes stage III melanoma following complete resection for pediatric patients 12 years and up.
Heading out of November and into December, plenty of companies had clinical trial news to report. Here’s a look.
Bayer has high hopes of driving its prostate cancer drug into blockbuster status, meaning over $1 billion in annual sales. This week’s ARASENS trial results should help pave the road.
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
The Phase III DISCREET study evaluated the efficacy of Otezla in adults who have been diagnosed with moderate to severe plaque psoriasis and genital psoriasis.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
The 12-month data showed that 50 mg of zuranolone was well-tolerated among adults with MDD.
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