Clinical research
The FDA is likely to push back the Prescription Drug User Fee Act target action date for Travere Therapeutics’ sparsentan by three months..
Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.
Tiziana Life Sciences plans to submit an Investigational New Drug Application for a Phase I trial studying intranasal formulab, a breakthrough treatment option for Alzheimer’s Disease.
GSK’s RSV vaccine candidate met its primary endpoint in a pivotal Phase III trial, proving to be highly effective against RSV-associated lower respiratory tract disease.
Relmada Therapeutics’ RELIANCE III trial studying REL-1017 as a treatment for Major Depressive Disorder failed to hit the primary endpoint, the company reported Thursday.
Novartis’ gene therapy Zolgensma is again under a cloud of doubt after Nature Biotechnology retracted its 2010 article noting “issues” regarding data cited in a key figure in the report.
Merck and Moderna are moving forward with a personalized cancer vaccine as Merck exercised its option to develop and commercialize mRNA-4157/V940, the companies announced Wednesday.
Incidence of gout - the most common inflammatory arthritis in the world - are on the rise. Arthrosi Therapeutics, Synlogic, Atom Bioscience and Ginkgo Bioworks are on the case with novel new approaches.
Forge Biologics’ novel gene therapy for Krabbe disease, a fatal neurodegenerative disorder, showed positive signals in a Phase I/II trial.
Albireo Pharma reported dazzling Phase III ASSERT data of Bylvay for Alagille syndrome (ALGS). The company is headed to U.S. and European regulators with expectations of regulatory filings in Q1 of 2023.
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