Food and Drug Administration (FDA)
NEWS
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Sernova shared positive Phase I/II data from an ongoing clinical study of its implantable Cell Pouch device that showed evidence of in vivo active insulin production.
The combination of Opdivo plus Yervoy in addition to chemotherapy demonstrated additional benefits in patient populations who usually have poor prognoses.
Legend Biotech and J&J, Adicet Bio, Curis and Immutep present optimistic early and mid-stage results at ASCO.
GSK’s MMR vaccine is only the second to be approved in the United States for protection against measles, mumps and rubella. The first, licensed to Merck, was approved in 1971.
Ibrance, a first-line treatment for ER+, HER2 - metastatic breast cancer, did not improve the overall survival rate in patients. Read on to know more.
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