Zacks Small Cap Research on MSN1d
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 Advisor2d
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 Insider16d
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 MSN8d
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 Times2d
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.
CURE16d
FDA Accepts NDA For Dordaviprone in H3 K27M-Mutant Diffuse Glioma
A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...
Yahoo Finance18d
XORTX Commences Gout Program NDA Discussions with the FDA
CALGARY, Alberta, Feb. 24, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANUA), a late stage ...