Boehringer seeks approval for lung fibrosis drug following Phase III win
Boehringer Ingelheim is seeking regulatory approval for nerandomilast after a Phase III trial in idiopathic pulmonary fibrosis (IPF) met its…
Respiratory
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Regeneron’s Dupixent approved as first adolescent CRSwNP treatment
The US Food and Drug Administration (FDA) has expanded the approval of Dupixent (dupilumab) to include adolescents aged 12 to…
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GSK’s asthma blockbuster Nucala secures win in COPD Phase III trial
GSK’s asthma drug Nucala (mepolizumab) has met the primary endpoint in a Phase III trial treating patients with chronic obstructive…
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NMPA approves AstraZeneca’s Fasenra for severe asthma
The China National Medical Products Association (NMPA) has approved AstraZeneca's Fasenra (benralizumab) as a maintenance treatment for individuals aged 12…
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Dupixent “addresses current gap” in COPD biologics landscape
The approval of Regeneron and Sanofi’s Dupixent (dupilumab) as the first targeted therapy for chronic obstructive pulmonary disease (COPD) has…
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Johnson & Johnson gains FDA and EC approvals for TB treatment
Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) and European Commission (EC) approvals for SIRTURO (bedaquiline)…
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Aerovate slashes workforce after failed Phase IIb trial
Aerovate Therapeutics is slashing its workforce by 78%, two weeks after the company announced a Phase IIb trial failure of…
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Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy
The US Food and Drug Administration (FDA) has approved Verona Pharma’s Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive…
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Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset
Six months after kicking off a Phase I trial for idiopathic pulmonary fibrosis (IPF) treatment AGMB-447, Agomab Therapeutics has now…
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EMA CHMP supports CStone’s sugemalimab for metastatic NSCLC
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of CStone's sugemalimab,…
