Clene is scheduled to meet with the FDA in the coming months to discuss new data for CNM-Au8, its experimental oral therapy ...
Considerable on MSN
Company reaches FDA deal on biomarkers
A healthcare company says it has secured an agreement with the U.S. Food and Drug Administration to use 12‑month biomarker ...
Why Beam Therapeutics Is Back On Investors’ Radar Beam Therapeutics (BEAM) is in focus after securing U.S. FDA alignment on a ...
6 min read | UniQure secured a Type A FDA meeting, a high-priority discussion for urgent issues. Within 30 days, both sides will discuss what kind of data package might support the advancement of ...
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late ...
NEW YORK, Oct. 07, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, ...
The third-line results build on equally compelling second-line data, where pelareorep achieved a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in ...
Stoke Therapeutics advances TANGO ASO for Dravet, with Zorevunersen Phase 3 data showing seizure reduction and a delayed 2027 ...
In this part 3 of our three-part interview, Stenberg explores the evolving manufacturing paradigm in the pharmaceutical ...
U.S. Food and Drug Administration (FDA) open to pooling data from ongoing Phase I/II studies of LX2006 with pivotal data to support a Biologics License Application (BLA) for Accelerated Approval ...
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