UniQure gets FDA nod for accelerated filing of Huntington's treatment, shares surge

June 17 (Reuters) - UniQure said on Wednesday the U.S. Food and Drug Administration has agreed existing trial data could ...
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FDA accepts Roche's filing for Lunsumio VELO-Polivy in LBCL

Roche RHHBY announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of ...

UniQure to seek approval for Huntington's therapy after FDA U-turn, shares skyrocket

Dutch drugmaker ​UniQure said ‌on Wednesday the ​U.S. ​Food and Drug ⁠Administration ​has agreed ​that data from a ​mid-stage ...
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uniQure sets course to US filing for Huntington gene therapy

The FDA refused to accept uniQure's filing for AMT-130 last November, and earlier this year the Dutch biotech said it had ...
RAPS

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when ...
Seeking Alpha

Biofrontera Announces FDA Filing Acceptance of Supplemental New Drug Application for Ameluz® PDT in Superficial Basal Cell Carcinoma

WOBURN, Mass., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization and development of ...
Benzinga.com

MoonLake Says FDA May Allow Skin Drug Filing Without New Trials, Stock Soars

MIRA trial data demonstrated a 43% response with 120mg SLK, and a 29 ppt delta vs placebo (p < 0.001) at week 12. VELA-1 met all primary and key secondary endpoints with statistical significance ...