The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.

A Maryland jury has convicted both former CytoDyn CEO Nader Pourhassan, Ph.D., and ex-Amarex CEO Kazem Kazempour on several ...

The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...

Ascendis Pharma (ASND) said the FDA has accepted for its supplemental Biologics License Application for TransCon hGH for the treatment of adult growth hormone deficiency, or GHD. The agency has set a ...

Ascendis Pharma announced that the FDA has accepted their supplemental Biologics License Application for TransCon hGH in treating adult growth hormone deficiency. The decision marks a significant step ...

Candel Therapeutics (NASDAQ:CADL) priced an underwritten public offering of 10M shares at $6.00 per share and pre-funded ...

Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth ...

In a Type B meeting, the FDA signified that it will allow uniQure to use a natural history control, the composite Unified ...

has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi ® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people ...

Shares of DBV Technologies were trading higher on the Nasdaq after hours Wednesday, following the company confirming alignment with the Food and Drug Administration on an accelerated approval for its ...