Oncology

Sapience receives orphan designation for ST101 to treat advanced melanoma

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, AstraZeneca’s ENHERTU gets BTD for HER2 Low Metastatic Breast Cancer

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.

FDA accepts AstraZeneca’s BLA review for tremelimumab to treat HCC

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 receives ODD for lead product TTI-101 to treat 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 gets FDA approval for metastatic melanoma therapy

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 gets orphan drug designation for NTLA-5001 to treat AML

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).

US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review

The US Food and Drug Administration (FDA) has accepted for review Spectrum Pharmaceuticals’ New Drug Application (NDA) for its therapy poziotinib.

Senhwa Biosciences receives ODD for Silmitasertib from FDA to treat biliary tract cancer

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 announces FDA acceptance for sBLA review of Libtayo with chemotherapy for NSCLC

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).