Amezalpat received fast track designation from the FDA for the treatment of patients with hepatocellular carcinoma.

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Shares of Biohaven Ltd. (NYSE: BHVN) climbed 7% as the company announced the FDA's acceptance and Priority Review of its ...

HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a late-stage pharmaceutical company currently trading near its 52-week low of $0.66, announced it has received the first European regulatory approval ...

Moleculin Biotech (MBRX) has received first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol ...

The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...

Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to read why ZYME stock is a Hold.

Grace Therapeutics intends to use the upfront net proceeds from the private placement for general corporate purposes and to fund pre-commercial development of GTx-104, a clinical stage, novel, ...

Trial Met the Primary Endpoint and Provides Evidence of GTx-104 Clinical Benefit Compared to Orally Administered Nimodipine. New Drug Application (NDA) Submission Expected in the ...

Tempest Therapeutics (TPST) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, to amezalpat, ...

Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food ...