Gastrointestinal
FDA approves Madrigal’s Rezdiffra as the first NASH therapy
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) has become the first drug to be approved by the US Food and Drug Administration (FDA)…
BeiGene’s TEVIMBRA application for gastric cancer accepted for review
BeiGene has announced the acceptance of a biologics licence application (BLA) by the US Food and Drug Administration (FDA) for…
Polpharma looks to challenge Takeda’s Entyvio in IBD
Netherland-based Polpharma Biologics has released top line results from a pharmacokinetic (PK) and pharmacodynamic (PD) study of its biosimilar candidate…
Celltrion’s Remsima SC for IBD gains approval in Canada
Celltrion Healthcare Canada has announced that its Remsima SC, a subcutaneous version of its infliximab biosimilar, has obtained approval for…
EC approves Merck’s Keytruda combo for gastrointestinal cancers
The European Commission (EC) has granted approval for Merck (MSD)'s anti-programmed death receptor-1 (PD-1) therapy, Keytruda, plus chemotherapy for two…
Ferring signs microbiome R&D partnership deal with PharmaBiome
Ferring Pharmaceuticals has signed a research and development (R&D) partnership and licensing agreement with Swiss-based company PharmaBiome to develop new…
FDA accepts Vanda Pharmaceuticals’ NDA for gastroparesis treatment
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA) filed by Vanda Pharmaceuticals for its…
Sosei to regain rights to IBD drug after GSK discontinues programme
Sosei Group Corporation has initiated discussions to regain full ownership of the oral inflammatory bowel disease (IBD) drug GSK4381406 from…
Vertex obtains EC approval for combination therapy to treat CF
Vertex Pharmaceuticals has obtained approval from the European Commission (EC) for the label expansion of Kaftrio (ivacaftor/tezacaftor/elexacaftor) plus ivacaftor to…
FDA grants approval for Merck’s Keytruda combo for gastric cancer
The US Food and Drug Administration (FDA) has granted approval for Merck’s (MSD) Keytruda (pembrolizumab) plus chemotherapy as a first-line treatment for…
