The US Food and Drug Administration (FDA) has accepted Merck’s (MSD) biologics license application (BLA) of sotatercept to treat pulmonary arterial hypertension [PAH (WHO Group 1)], for priority review.
Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for LYTGOBI (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA).
The US Food and Drug Administration (FDA) has granted clearance for Skyline Therapeutics’ investigational new drug (IND) application for Phase I/IIa clinical trial of gene therapy SKG0106 to treat neovascular age-related macular degeneration (nAMD).
Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001.
Amgen has reported positive end-of-treatment data from the Phase II OCEAN(a)-DOSE study of its investigational olpasiran (formerly AMG 890).
Erasca and Eli Lilly and Company have signed a clinical trial partnership and supply agreement to evaluate ERAS-007, an oral ERK1/2 inhibitor, in combination with Eli Lilly's anti-EGFR antibody cetuximab (ERBITUX).
The US Food and Drug Administration (FDA) has granted approval to Avacta Group’s Investigational New Drug (IND) application for AVA6000, a new form of doxorubicin.
Moleculin Biotech has received authorisation to begin a Phase Ia clinical trial of its drug, WP1122, in the UK to treat Covid-19.
Pfizer has dosed the first subjects in a Phase I clinical trial to test an influenza vaccine which is developed using mRNA technology.
Hookipa Pharma has signed a clinical collaboration and supply agreement with Merck to assess HB-200 in combination with Keytruda (pembrolizumab) in patients with advanced head and neck squamous cell carcinoma (HNSCC).
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