Sapience Therapeutics has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead programme, ST101, to treat advanced melanoma for patients in stages IIB through IV.
Daiichi Sankyo and AstraZeneca’s ENHERTU (fam-trastuzumab deruxtecan-nxki) has secured breakthrough therapy designation (BTD) in the US to treat adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.
The US Food and Drug Administration (FDA) has accepted for review AstraZeneca’s Biologics License Application (BLA) for tremelimumab to treat patients with unresectable hepatocellular carcinoma (HCC).
Tvardi Therapeutics, a clinical-stage biopharmaceutical company, has announced receipt of orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its lead product, TTI-101, to treat hepatocellular carcinoma (HCC).
Bristol Myers Squibb has obtained approval from the US Food and Drug Administration (FDA) for Opdualag (nivolumab and relatlimab-rmbw) to treat unresectable or metastatic melanoma patients.
Intellia Therapeutics has secured orphan drug designation from the US Food and Drug Administration (FDA) for its ex vivo investigational T cell receptor (TCR)-T cell therapy, NTLA-5001, to treat acute myeloid leukemia (AML).
The US Food and Drug Administration (FDA) has accepted for review Spectrum Pharmaceuticals’ New Drug Application (NDA) for its therapy poziotinib.
Senhwa Biosciences has announced the receipt of Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for Silmitasertib, a highly selective inhibitor of casein kinase 2 (CK2) to treat patients with biliary tract cancer (BTC).
Regeneron Pharmaceuticals has announced the acceptance of U.S. Food and Drug Administration (FDA) for review of the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) along with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC).
Biotechnology firm Neogene Therapeutics has signed an exclusive, global license agreement with the National Cancer Institute (NCI) for a portfolio of T cell receptor (TCRs) targeting KRAS and TP53 mutations for the treatment of patients suffering with cancer.
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