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…
Oncology
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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…
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WHO and St Jude start distributing paediatric cancer medicines amid US aid cuts
At a time when the US is pausing much of its international aid initiatives, the World Health Organization (WHO) and…
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Dr Reddy’s and Shanghai Henlius sign agreement for HLX15
Dr Reddy's Laboratories has signed a licence agreement with Shanghai Henlius Biotech to develop and commercialise HLX15, a daratumumab biosimilar…
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USC receives grant for gene therapy targeting glioblastoma
The University of Southern California (USC) has received a $6m grant from the California Institute for Regenerative Medicine (CIRM) to…
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AstraZeneca lung cancer therapy Imfinzi recommended for EU approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended AstraZeneca's Imfinzi (durvalumab) for approval in the…
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Sanofi’s Sarclisa combo approved in China for multiple myeloma
Sanofi has received China’s National Medical Products Administration (NMPA) approval for the use of Sarclisa (isatuximab), combined with a standard-of-care…
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FDA grants ODD status to Zai Lab’s lung cancer treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3)…
