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ALDX crashes 71% as FDA issues third CRL for dry eye disease drug NDA
Shares of Aldeyra Therapeutics ALDX plunged 70.7% on Tuesday after the company announced receiving a Complete Response Letter ...
On-track progress for the New Drug Application (NDA) for paltusotine, with a PDUFA target action date set for September 25, 2025, indicating strong engagement with the FDA. Marketing authorization ...
Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance ...
Singh maintained guidance that "we'll see top line results released before the end of this calendar quarter, so by the end of this calendar year" for PALISADE-3. Singh projected that top line results ...
The FDA accepts the NDA for lorundrostat, a selective aldosterone synthase inhibitor, for adults with uncontrolled or resistant hypertension.
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Achieve Life Sciences targets NDA submission for cytisinicline in June 2025 as open label study hits key milestones
CEO Rick Stewart stated that "Achieve is on track to submit the NDA for cytisinicline next month." He emphasized that "all internal resources are now focused on a successful NDA submission, acceptance ...
TOKUSHIMA, Japan--(BUSINESS WIRE)--150 patients have been enrolled at the multi-clinical centers in US to the Phase 3 randomized trial of DFP-10917 vs non-intensive reinduction (LoDAC, Azacytidine, ...
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