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…
Respiratory
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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,…
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FDA approves Moderna’s RSV vaccine mRESVIA
Moderna has secured approval from the US Food and Drug Administration (FDA) for its mRNA-based respiratory syncytial virus (RSV) vaccine…
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Amgen and AstraZeneca ponder label expansion for Tezspire in COPD
Amgen and AstraZeneca have highlighted the potential of Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD) in a subgroup of…
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Dupixent set for FDA review in adolescent chronic inflammatory sinus disease
Regeneron and Sanofi could soon be adding another indication to its blockbuster immunology drug Dupixent (dupilumab) after the US Food…
