Regulatory
Horizon Discovery Group plc announces its results for the six months ended 30 June 2019.
Law firm urges Zantac users to find out their rights against drug maker who knowingly sold potentially carcinogenic medication
Auris Medical Holding Ltd. announced that it has obtained advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen® from the U.S. Food and Drug Administration and from the European Medicines Agency.
Akari Therapeutics, Plc announced that the U.S. Food and Drug Administration has granted orphan drug designation for nomacopan for the treatment of bullous pemphigoid.
Silence Therapeutics, PLC announces its unaudited interim results for the half year to 30 June 2019.
Received Notice of Allowance from United States Patent and Trademark Office -- Received “Intention to Grant” notice from European Patent Office
Advanced Medical Solutions Group plc announces its unaudited interim results for the six months ended 30 June 2019.
Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced plans to submit a supplemental Biologics License Application to the U.S. Food and Drug Administration for Crysvita® for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.
ProBioGen AG announced the closing of a license agreement with Bayer AG for the GlymaxX® Technology.
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