We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sanofi and GlaxoSmithKline have begun enrolling participants in a global phase 3 trial of their COVID-19 vaccine candidate that could potentially lead to a regulatory approval in the fourth quarter of 2021. Read More
Less than 40 percent of clinical trials active in ClinicalTrials.gov over the past four years were in compliance with FDA reporting requirements, a new analysis of the federal database revealed. Read More
The FDA has placed Larimar Therapeutics’ phase 1 trial of its experimental Friedrich’s ataxia drug, CTI-1601, on clinical hold, a significant setback for the company as the recombinant fusion protein is the only drug candidate in its pipeline. Read More
As Emergent BioSolutions works rapidly to deal with problems at its Bayview, Md., facility and get production of the Johnson & Johnson (J&J) COVID-19 vaccine back online, the company is reporting some good vaccine news, announcing positive two-year mid-stage trial results for its chikungunya virus vaccine hopeful. Read More
Moderna said its COVID-19 vaccine offered strong protection against infection in adolescents ages 12 to 17 years in a phase 2/3 study, paving the way for the company to seek a revised Emergency Use Authorization that covers this population. Read More
The FDA is reviewing Pfizer’s Biologics License Application for 20vPnC under a Priority Review designation and the agency’s decision is anticipated in June. Read More
Takeda Pharmaceutical’s dengue vaccine candidate, TAK-003, offered strong continued protection against dengue fever, especially infection requiring hospitalization, for up to three years with no significant safety risks, according to a late-stage study. Read More