Government
More flexible versions of the COVID-19 diagnostic tests are being developed but, currently, are only available for research.
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Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population.
In a statement issued to the Boston Business Journal, Intarcia expressed both disappointment and a determination to get an approval for ITCA 650.
The Breakthrough Therapy Designation is based on data from a Phase I trial of JNJ-6372 alone and in combination with lazertinib, a novel third-generation EGFR TKI in adults with advanced NSCLC.
The company disclosed that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I trial for non-Hodgkin lymphoma due to a safety concern.
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s Ofev (nintedanib) for patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
Novartis’ Isturisa (osilodrostat) was approved for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease.
Although March looks to be a busy month for the U.S. Food and Drug Administration, several of the PDUFA dates for this week were for drugs under Priority Review.
Glaucoma is a progressive disease of the eye that can lead to irreversible vision loss and blindness.
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