Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.
Ardelyx (ARDX) announced the approval of a New Drug Application, NDA, by China’s Center for Drug Evaluation of the National Medical Products Administration for tenapanor to control serum ...
Pharmaceutical Technology on MSN10d
Indonesia approves Antengene’s Xpovio NDA for multiple indicationsAntengene’s new drug application (NDA) for Xpovio (selinexor) has gained approval from the Indonesia National Agency of Drug ...
The NDA approval for tenapanor in China supports Ardelyx's goal of addressing significant unmet medical needs in patients with chronic kidney disease. The approval triggers a $5 million milestone ...
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
Supplemental New Drug Application (sNDA) submission anticipated in 3Q 2025NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- Axsome ...
The FDA is reviewing the supplemental NDA for cabozantinib in adults with ... The Company is seeking approval for acute treatment of migraine with or without aura.
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