Zacks Small Cap Research on MSN3d
ACHV: 2Q:25 NDA Submission
ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with ...
Pulmonology Advisor4d
FDA Drug Approval Decisions Expected in April 2025
Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.
Business Insider17d
Ardelyx announces approval of NDA by China for tenapanor
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 indications
Antengene’s new drug application (NDA) for Xpovio (selinexor) has gained approval from the Indonesia National Agency of Drug ...
Ophthalmology Times4d
FDA accepts new drug application for low-dose atropine from Sydnexis
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
FDA files Corcept’s NDA for Relacorilant as treatment in Hypercortisolism
Corcept Therapeutics (CORT) announced that the FDA filed its New Drug Application (NDA) submission for its proprietary, selective cortisol ...
Monthly Prescribing Reference10d
FDA Drug Approval Decisions Expected in April 2025
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.