Checkpoint said in July that the FDA accepted for review its resubmission of the Biologics License Application for the drug and set a Prescription Drug User Fee Act goal date of Dec. 28. Shares were ...
A Maryland jury has convicted both former CytoDyn CEO Nader Pourhassan, Ph.D., and ex-Amarex CEO Kazem Kazempour on several ...
The sBLA submission included results from the randomized, parallel-arm, placebo-controlled and active-controlled trial foresiGHt.
AstraZeneca AZN announced that the FDA has accepted and granted priority review to its supplemental biologics license ...
The FDA will allow uniQure NV to seek accelerated approval for its Huntington’s disease gene therapy more than doubled the ...
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 ...
Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth ...
Candel Therapeutics (NASDAQ:CADL) priced an underwritten public offering of 10M shares at $6.00 per share and pre-funded ...
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 ...
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