Hikma’s epinephrine nasal spray advances into regulatory review
Hikma ($HIK) said regulators in the United States, Europe and the UK have accepted submissions for its investigational epinephrine nasal spray for review. The company has also filed in Canada and intends to expand submissions to additional markets. The product is being developed for emergency treatment of severe allergic reactions, offering a potential non-injectable delivery option. The US application follows the 505(b)(2) regulatory pathway and is supported by the company’s clinical and noncli
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