Clinical research
They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
CT38 is being studied in myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS), as well as in fibromyalgia and chronic Lyme disease.
Today’s approval was based on the Phase III KEYNOTE-826 trial that evaluated Keytruda and chemotherapy with or without bevacizumab compared to the same chemotherapy treatment.
BrainStorm announced positive data from a Phase II safety and efficacy study of NurOwn in progressive MS on Thursday morning.
Modern radiation therapy is tightly targeted to dramatically reduce toxicity and side effects and often can be administered on an outpatient basis.
At the virtual Congress of the ECTRIMS meeting this week, multiple companies present data for ongoing studies of therapies for multiple sclerosis. BioSpace takes a look at some of the data.
Less private investment and innovation in the development of new antibiotics are impeding efforts to combat drug-resistant infections.
The drug is limited to patients who test at least 20% for a Ki-67 score on an FDA-approved test.
CRISPR Therapeutics provided updated data from its ongoing Phase I CARBON trial of CTX110, its allogeneic “off-the-shelf” CAR-T therapy for CD19+ B-cell cancers.
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