China’s CDE grants breakthrough status approval to Abbisko’s HCC therapy
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation approval to Abbisko…
Gastrointestinal
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J&J’s Tremfya gains EC marketing authorisation for ulcerative colitis
The European Commission (EC) has granted marketing authorisation for Johnson & Johnson's (J&J) Tremfya (guselkumab) to treat adults with moderately…
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BMS’ Opdivo combo approved in US for hepatocellular carcinoma
The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in combination with…
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FDA approves Johnson & Johnson’s Tremfya to treat Crohn’s disease
Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) approval for its interleukin 23 inhibitor, Tremfya (guselkumab),…
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EC approves BMS’ Opdivo and Yervoy combo for HCC
The European Commission (EC) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) in combination with the recombinant human monoclonal…
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FDA approves BeiGene’s Tevimbra plus chemo for oesophageal cancer
The US Food and Drug Administration (FDA) has approved BeiGene’s Tevimbra (tislelizumab-jsgr) along with platinum-containing chemotherapy as first-line treatment for…
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FDA accepts BMS’ Opdivo-Yervoy combo sBLA for colorectal cancer
The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence application (sBLA) for an…
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FDA grants fast track status to Rznomics’ RZ-001 for HCC
The US Food and Drug Administration (FDA) has granted fast track designation to Rznomics' RZ-001 for the treatment of hepatocellular…
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FDA breakthrough status for Bluejay’s CHD therapy brelovitug
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to Bluejay Therapeutics’ fully human immunoglobulin G1 (IgG1)…
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Health Canada gives Takeda’s mCRC capsules market authorisation
Health Canada has granted market authorisation to Takeda Canada for FRUZAQLA (fruquintinib) capsules to treat adults with metastatic colorectal cancer…
