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FDA
The U.S. Food and Drug Administration posted analyses of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 years old ahead of Tuesday’s vaccines advisory committee meeting.
The two Phase III studies are part of the ILLUMINATE clinical trial, which looks into the action of doravirine/islatravir (DOR/ISL) on HIV-1.
Xipere was approved for suprachoroidal use for the macular edema treatment. Macular edema is associated with uveitis, it is a form of eye inflammation.
The ongoing criminal trial of Holmes revealed Elizabeth Holmes and Theranos issued marketing materials to future partner Walgreens that included the use of Pfizer’s corporate logo.
Bristol Myers Squibb is reportedly courting Canada’s Aurinia Pharmaceuticals to strike a buyout deal.
Researchers found improvements in the study’s co-primary endpoints in patient-reported measures of esophageal inflammation and difficulty swallowing.
Novartis announced the CANOPY-1 Phase III trial of canakinumab failed to meet its primary endpoints when combined with Merck’s checkpoint inhibitor Keytruda (pembrolizumab).
C2i Genomics plans to make sophisticated AI-informed cancer diagnostics and tumor monitoring available throughout the world, regardless of where patients or clinical trials are located.
FDA
The U.S. FDA has a busy period at the end of October heading into the first week of November.
It was yet another busy week for clinical trial news. Here’s a look.
A growing number of studies show that though natural immunity can work, hybrid immunity through vaccination could be better. They urge faster vaccination drives.
FDA
Lexington, Mass.-based Agenus withdrew its Biologics License Application for balstilimab from the U.S. FDA. The drug is a PD-1 inhibitor or checkpoint inhibitor.
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