Indonesia approves Antengene’s Xpovio NDA for multiple indications
Antengene’s new drug application (NDA) for Xpovio (selinexor) has gained approval from the Indonesia National Agency of Drug and Food…
Oncology
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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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EU set to approve AstraZeneca’s Imfinzi-chemo combo for NSCLC
AstraZeneca's Imfinzi (durvalumab) plus chemotherapy combo has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)…
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FDA grants fast track status to Pyxis’ PYX-201
The US Food and Drug Administration (FDA) has granted fast track designation to Pyxis Oncology’s antibody-drug conjugate (ADC), PYX-201, to…
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Sanofi’s Sarclisa combo approved in Japan for newly diagnosed MM
Sanofi's Sarclisa (isatuximab) has gained approval from Japan’s Ministry of Health, Labour and Welfare for use in conjunction with bortezomib,…
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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 authorises ImmunityBio’s BCG alternative to treat bladder cancer
ImmunityBio has gained US Food and Drug Administration (FDA) authorisation for an expanded access programme to supply an alternative source…
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FDA grants priority review for Boehringer’s zongertinib NDA in NSCLC
The US Food and Drug Administration (FDA) has granted priority review to Boehringer Ingelheim’s new drug application (NDA) for zongertinib…
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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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AbbVie and Xilio to collaborate on antibody-based immunotherapies
AbbVie has entered a partnership and option-to-license agreement with Xilio Therapeutics to develop new tumour-activated, antibody-based immunotherapies. The initiative will…
