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Tolvaptan was approved by the U.S. Food and Drug Administration (FDA) on May 19, 2009, and is sold by Otsuka Pharmaceutical Co. under the trade name Samsca. [9] Tolvaptan, as Jynarque, was granted approval for medical use in the United States in April 2018.
Rejoyn was developed by Otsuka America Pharmaceutical Inc., and gained FDA approval as a "medical device" on March 30th, 2024. [3] The smartphone app helps patients with depression using exercises based on cognitive behavioral therapy (CBT) along with timed notifications to keep the patient engaged and in treatment.
The approval for Paradise Ultrasound Renal Denervation comes after an FDA panel backed its use. The device is made by Japanese company Otsuka's unit ReCor and is indicated for use in patients ...
In March 2017, the company agreed to acquire Neurovance, Inc. for $250 million, gaining the firm's Phase III-ready ADHD drug centanafadine (previously EB-1020). Otsuka's subsidiary Otsuka America will pay $100 million upfront for Neurovance, plus up-to $150 million in development and approval milestones.
The FDA staff's assessment comes ahead of meetings of two independent expert panels next week, where they will make recommendations on whether or not to approve the devices for treatment. The ...
Palo Alto, CA, July 25, 2024 (GLOBE NEWSWIRE) -- Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced the first patients in the US have been treated in Recor Medical’s Global Paradise® System US Post Approval Study (US GPS), a real-world study gathering data on the long-term safety and effectiveness of ...
Centanafadine (former developmental code name EB-1020) is a serotonin-norepinephrine-dopamine reuptake inhibitor (SNDRI) that began its development with Euthymics Bioscience after they acquired DOV Pharmaceutical.
(Reuters) -A panel of advisers to the U.S. Food and Drug Administration (FDA) on Tuesday recommended the use of a device made by a unit of Otsuka Holdings in a type of surgery to treat high blood ...