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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 ...
Inovio’s upside hinges on INO-3107 for HPV-6/11 RRP with FDA PDUFA Oct 2026, regulatory risk, tight cash, and cheap EV. Check ...
Atara Biotherapeutics (NASDAQ: ATRA) has developed Ebvallo (tabelecleucel), a novel second-line immunotherapy for Epstein–Barr virus–positive post-transplant lymphoproliferative disease (EBV-PTLD).
Stoke Therapeutics advances TANGO ASO for Dravet, with Zorevunersen Phase 3 data showing seizure reduction and a delayed 2027 ...
The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...
On track to define optimal dosing interval and advance manufacturing scale up of REYOBIQ for pivotal trial readiness in late ...
In this part 3 of our three-part interview, Stenberg explores the evolving manufacturing paradigm in the pharmaceutical ...
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 ...
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 ...
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