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 ...
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 New Draft Guidance Explains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 ...
Seeking Alpha

Pacira down after FDA filing for generic Exparel

Shares of Pacira BioSciences (NASDAQ:PCRX) fell on Tuesday after the company announced that a subsidiary of a Chinese drugmaker has filed a marketing application seeking U.S. approval of a generic ...
Nasdaq

FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib (Revised)

Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis ...