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Actelion Receives Complete Response Letter from FDA for OPSUMIT americanpharmaceuticalreview
January 21, 2019
Actelion Pharmaceuticals has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for OPSUMIT® (macitentan) in the treatment of ....
FDA grants breakthrough device designation to Bayer, Merck’s AI for spotting CTEPH fiercebiotech
January 02, 2019
The FDA granted Bayer and Merck & Co. a breakthrough device designation for an artificial intelligence-based pattern recognition software used to spot a rare form of pulmonary hypertension in CT scans......
FDA breakthrough designation for Bayer and Merck & Co’s AI software pharmaphorum
December 05, 2018
Bayer and Merck & Co have won a breakthrough device designation from the US regulator FDA for artificial intelligence software they are jointly developing.
NHS to fund balloon pulmonary angioplasty in the UK pharmatimes
July 19, 2018
NHS England is funding a pioneering procedure that will improve treatment outcomes for patients with a lung disease called Chronic Thromboembolic Pulmonary Hypertension (CTEPH).