LEXINGTON, Mass. and AMSTERDAM, Jan. 09, 2026 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing ...
Qure N.V. (NASDAQ:QURE) surged around 15% in early trading on Friday after the company said it has secured a Type A meeting ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical ...
MoonLake regains momentum after the FDA Type B meeting allows BLA submission for sonelokimab in HS without additional trials.
Shares of UniQure were higher after the gene therapy company said it had scheduled a Type A meeting with the Food and Drug Administration to discuss a Biologics License Application for the company's ...
Qure N.V. (NASDAQ:QURE) shares are popping on Friday after the company said the FDA will review the data package for AMT‑130, ...
In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer ...
MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License ...
Investing.com -- uniQure N.V. (NASDAQ:QURE) stock rose 15% Friday morning after the gene therapy company announced a scheduled Type A meeting with the U.S. Food and Drug Administration (FDA) to ...
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late ...
The submission follows a Type C meeting with the FDA in December 2025 to discuss the proposed accelerated approval pathway. The amendment is supported by positive final results from the company’s ...
New Drug Application (NDA) submission on track for January 2026NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: ...
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