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China’s I-Mab biopharma gets USFDA’s approval for IND application for TJM2

A China-based clinical stage biopharmaceutical immuno-oncology and autoimmune diseases focused company, I-Mab Biopharma (I-Mab), said Monday it got the US Food and Drug Administration (FDA) has approval for its IND application for TJM2, a potential treatment for autoimmune and inflammatory diseases.

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GenomOncology names CEO

GenomOncology, a technology solution provider for oncology, named Brad Wertz as the new Chairman and Chief Executive Officer (CEO), who’ll assume the position from the start of year 2019.  Wertz has been a founding investor and chairman of the board since the beginning, and has increased his involvement as the company has grown over the past two years. 

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First Japanese company joins CARB-X partnership in the fight against drug resistant bacteria

CARB-X is partnering with Shionogi of Osaka, Japan, to support the development of a novel β-lactam antibiotic with potent activity

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Hikma launches Ritonavir Tablets USP

Hikma Pharmaceuticals’s wholly owned US subsidiary West-Ward Pharmaceuticals, has launched Ritonavir Tablets USP, 100 mg, the first AB-rated generic to

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BMS welcomes new Board member

Bristol-Myers Squibb’s Board of Directors has elected José Baselga, M.D., Ph.D., to the Board, effective March 1, 2018. Dr. Baselga will

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Novo Nordisk files for regulatory approval in the US and the EU for treatment of haemophilia A

Novo Nordisk has submitted a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing

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FDA rejects Celgene’s NDA for multiple sclerosis treatment

Celgene Corporation (NASDAQ:CELG) has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug

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Lillys breast cancer drug gets additional FDA approval

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s (NYSE: LLY) Verzenio (abemaciclib) in combination with an aromatase

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FDA accepts sNDA filing for Allergan’s pneumonia drug

The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Allergan’s Avycaz (ceftazidime and avibactam) for priority review.

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Eli Lilly in leadership chances

Eli Lilly has made certain leadership changes, promoting several experienced Lilly leaders to executive roles, effective in 2018.

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