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.
A clinical-stage global biopharmaceutical group company AnHeart Therapeutics has completed a $61m Series B financing round that was led by new investor Octagon Capital.
Recursion, a clinical-stage biotechnology company, has announced a collaboration with Roche and Genentech, a member of the Roche Group.
The US Food and Drug Administration (FDA) has granted priority review to AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) to treat BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer patients.
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