Phase 3
The rejection appears to be related to pre-approval inspection issues that need to be resolved before it can be approved.
Marinus shared positive news in its financial report for the first quarter, led by updates from its Phase III trial on a drug for RSE and research efforts for rare diseases.
BridgeBio announced it has signed an exclusive deal with Bristol-Myers Squibb to develop and commercialize a potential treatment for cancer.
Boston-based X4 Pharmaceuticals reported its first-quarter financial report today. Of note was the company’s cash, cash equivalents & restricted cash, which was $67.7 million as of March 31, 2022.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
In its financial results for 2021, Takeda announced that it has decided to discontinue the development of TAK-609, a therapeutic for Hunter Syndrome.
The FDA has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant, setting a precedent for upcoming COVID-19 treatments.
Jacqueline Shea will take over as the new CEO and announced plans to discontinue its Phase III Innovate trial to prioritize its heterologous booster strategy for COVID-19.
AstraZeneca and Sanofi’s Phase-III and Phase-IIb clinical trials investigating the efficacy of nirsevimab shows 79.5% efficacy in the prevention of lower respiratory tract infections.
Genentech (Roche) reported Wednesday that its Phase III SKYSCRAPER-01 trial failed to meet its co-primary endpoint of progression-free survival (PFS).
PRESS RELEASES