Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the National Medical Products Administration (NMPA) ...

FDA granted priority review to Zepzelca plus Tecentriq for first-line maintenance in extensive-stage small cell lung cancer.

China NMPA accepts and grants priority review status to ArkBio's NDA for Azstarys to treat ADHD in patients aged six years and above: Shanghai, China Tuesday, June 17, 2025, 10:00 ...

Regulatory action was based on data from the Phase III IMforte trial, which showed that Zepzelca plus Tecentriq significantly ...

The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid ...

The FDA has accepted for Priority Review the New Drug Application for TransCon CNP (navepegritide) for the treatment of children with achondroplasia.

Jazz Pharmaceuticals (NASDAQ:JAZZ) announced Tuesday that the U.S. Food and Drug Administration (FDA) granted priority review ...

Lurbinectedin plus atezolizumab significantly reduced the risk of disease progression or death by 46% compared with atezolizumab alone.

The FDA has accepted for priority review the new drug application for sevabertinib (BAY 2927088) to treat certain patients with NSCLC.

The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for ziftomenib, an investigational ...

The BLA was supported by the Phase III VISIONARY trial data. GlobalData believes that sibeprenlimab’s latest priority review further signifies the drug’s major advantages over existing ...

CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid ...