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FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

Pfizer Inc. and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration has accepted and granted Priority Review for the companies’ supplemental New Drug Application for XTANDI® for the treatment of patients with non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.

FDA Grants Priority Review for XTANDI® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence Read More »

Genentech Provides Update on Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer

Genentech, a member of the Roche Group, has been made aware of an inadvertent disclosure of the second interim analysis of the Phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq® versus Tecentriq alone as an initial treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer.

Genentech Provides Update on Phase III SKYSCRAPER-01 Study in PD-L1-High Metastatic Non-Small Cell Lung Cancer Read More »

Recor Medical and Otsuka Medical Devices Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension

Recor Medical, Inc. and its parent company, Otsuka Medical Devices Co., Ltd. announce the U.S. Food and Drug Administration Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application for the Paradise™ Ultrasound Renal Denervation system, indicated to reduce blood pressure in patients with hypertension.

Recor Medical and Otsuka Medical Devices Announce Positive Vote from U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on the Paradise™ Ultrasound Renal Denervation System for the Treatment of Hypertension Read More »

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