The approval is based on its Phase III REACH3 trial, which evaluated Jakafi versus the best available therapy for treating chronic GVHD after allogeneic stem cell transplantation.
The Phase I randomized, double-blind, placebo-controlled, single ascending dose study will assess the tolerability and safety of the compound PDC-APB when delivered via intramuscular injection.
It earned the FDA’s green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response.
The Phase III COSMIC-311 trial for CABOMETYX delivered favorable final results in terms of objective response rate, progression-free survival, median overall survival, and safety.
Researchers from the Institute for Systems Biology observed 105 participants and found that failing or succeeding at shedding pounds is linked to one’s gut microbiome.
The Phase II/III trial showed a favorable safety profile and “robust” neutralizing antibody responses in children five to 11 years old who received two 10 µg doses of the vaccine at 21 days apart.
The FDA’s IND approval sets the stage for the very first Phase I/II trial to evaluate EBT-101 as a functional cure for chronic HIV based on the endpoints of safety, tolerability, and efficacy.
The FDA awarded a number of designations for Takeda’s candidate drug EXKIVITY in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
FDA has been actively greenlighting a number of efforts over the last few days to push therapies for rare or serious diseases that have largely unmet medical needs. Here’s a look.
According to the study, people who get sick enough to be hospitalized due to the virus might eventually suffer from a full-blown autoimmune disease later on.
Lightstone Ventures recently announced the closing of Lightstone Ventures III, securing $375 million to invest in early-stage firms that develop high-impact technologies that can change lives.
Zabdeno, a two-dose heterologous vaccine, was well-tolerated and induced antibody responses to the Zaire ebolavirus species 21 days after the second dose in 98% of all participants.
The Phase II study showed enhanced immune memory response to the virus in 96% of vaccinated subjects, all of whom were exposed to an environment dominated by the delta variant.
