Latest News for: bla

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uniQure Announces Plan for BLA Submission for AMT-130 in Huntington’s Disease

Nasdaq Globe Newswire 17 Jun 2026
~ 3-year analysis from the Phase I/II study can serve as the primary basis of a Biologics License Application for accelerated approval with FDA ~ ... .
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uniQure Announces Plan for BLA Submission for AMT-130 in Huntington’s Disease (Form 8-K) (uniQure NV)

Public Technologies 17 Jun 2026
uniQure Announces Plan for BLA Submission for AMT-130 in ... ~ Company intends to submit the BLA in third quarter of 2026 ~ ... The Company intends to submit the BLA in the third quarter of 2026.
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Inhibrx Announces U.S. FDA Acceptance of BLA for Ozekibart in Patients with Conventional Chondrosarcoma

Missoulian 16 Jun 2026
No filing review issues identified by FDA with PDUFA goal date set for April 14, 2027If Approved, Ozekibart Would Be the First and Only FDA-Approved Treatment for Unresectable or Metastatic Conventional Chondrosarcoma ... .
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MEDIPOST Secures FDA Agreement on Single Pivotal Phase 3 Study with Confirmatory Evidence BLA Filing Strategy for CARTISTEM® in the U.S.

PR Newswire 04 Jun 2026
and Canada. By securing this agreement, MEDIPOST seeks to accelerate CARTISTEM®'s U.S ... clinical development timeline and clinical development costs with an earlier BLA filing timepoint, which could facilitate an expedited commercial entry to the U.S ... .
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Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA (Form 8-K) (Replimune Group Inc)

Public Technologies 29 May 2026
Replimune Announces Planned RP1 BLA Resubmission Following Productive Discussion with FDA ... The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA ...
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Quetta railway bombing and the expansion of Baloch insurgency in Pakistan

Blitz 27 May 2026
On May 24, 2026, there was a suicide car bomb attack by the Baloch Liberation Army (BLA) near the railway area in Quetta, Balochistan ... The BLA claimed responsibility for these attacks, stating.
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