The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vertex Pharmaceuticals’ triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), for treating cystic fibrosis (CF) in individuals aged six years and above.
The US Food and Drug Administration (FDA) has granted priority review to Dizal's new drug application (NDA) for sunvozertinib aimed at treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.
China's National Medical Products Administration (NMPA) has granted approval to the second new drug application (NDA) of Innovent Biologics’ ROS1 tyrosine kinase inhibitor (TKI), DOVBLERON (taletrectinib adipate capsule) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Dyadic International has received a $3m grant from the Bill & Melinda Gates Foundation to develop monoclonal antibodies (mAbs) for the treatment of respiratory syncytial virus (RSV) and malaria.
AstraZeneca and Daiichi Sankyo have submitted a new biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking accelerated approval for datopotamab deruxtecan (Dato-DXd) to treat non-small cell lung cancer (NSCLC).
The US Food and Drug Administration (FDA) has granted approval for Verona Pharma’s Ohtuvayre (ensifentrine) as maintenance therapy for chronic obstructive pulmonary disease (COPD) in adults.
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Agomab Therapeutics’ AGMB-447, an inhaled small molecule ALK5-inhibitor, for treating idiopathic pulmonary fibrosis (IPF).
GlaxoSmithKline (GSK) has acquired all outstanding shares of Canadian biopharmaceutical firm Bellus Health for a total equity price of $2bn or $14.75 for each share in cash.
China National Medical Products Administration has accepted the review of GSK’s drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
ReCode Therapeutics has announced that it will secure a strategic investment from the Cystic Fibrosis Foundation (CF Foundation) to develop its inhaled mRNA-based therapeutic for cystic fibrosis (CF).
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