EC approves AstraZeneca’s Imfinzi combo for NSCLC
The European Commission (EC) has granted approval for AstraZeneca's Imfinzi plus chemotherapy for treating resectable non-small cell lung cancer (NSCLC)…
Respiratory
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Apollomics and LaunXP agree on NSCLC treatment in Asia
Apollomics and LaunXP have signed an agreement to develop and commercialise the former’s c-Met inhibitor vebreltinib combined with an epidermal…
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EMA to review GSK’s Nucala for COPD treatment expansion
The European Medicines Agency (EMA) has agreed to review GSK’s application of expanding Nucala’s (mepolizumab) use as add-on maintenance for…
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FDA ODD given to Plus Therapeutics’ injectable radiotherapy
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Plus Therapeutics’ injectable radiotherapy, Rhenium (186Re)…
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EU set to approve AstraZeneca’s Imfinzi-chemo combo for NSCLC
AstraZeneca's Imfinzi (durvalumab) plus chemotherapy combo has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)…
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FDA grants priority review for Boehringer’s zongertinib NDA in NSCLC
The US Food and Drug Administration (FDA) has granted priority review to Boehringer Ingelheim’s new drug application (NDA) for zongertinib…
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AstraZeneca lung cancer therapy Imfinzi recommended for EU approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended AstraZeneca's Imfinzi (durvalumab) for approval in the…
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FDA grants ODD status to Zai Lab’s lung cancer treatment
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Zai Lab’s delta-like ligand 3 (DLL3)…
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InflaRx wins EU approval for Gohibic in Covid-19-induced ARDS
The European Commission (EC) has granted marketing authorisation under exceptional circumstances for InflaRx’s Gohibic (vilobelimab) for the treatment of SARS-CoV-2-induced…
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China’s NMPA prioritises HUTCHMED’s lung cancer therapy review
China National Medical Products Administration (NMPA) has granted acceptance and priority review for the new drug application (NDA) for HUTCHMED’s…
