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…
Respiratory
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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…
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Innovent and Roche link on lung cancer therapy development
Innovent Biologics and Roche have entered a partnership and exclusive licence agreement to accelerate the development of a delta-like ligand…
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AstraZeneca’s Tagrisso gains EC approval for NSCLC treatment
AstraZeneca has gained approval from the European Commission (EC) for its oral therapy, Tagrisso (osimertinib), to treat adults with locally…
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Abera and Orexo partner for vaccine powder formulations
Abera Bioscience and Orexo have entered a partnership to develop and test the powder formulations of the former’s vaccine candidates…
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Petrovax announces positive results from long-CoV-III-21 trial of Longidaza for long-term pulmonary sequelae of COVID-19
Petrovax has announced encouraging findings from the Long-CoV-III-21 trial, a randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of…
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China NMPA approves MSD’s KEYTRUDA for stages of NSCLC
China National Medical Products Administration (NMPA) has approved MSD’s KEYTRUDA for use in conjunction with platinum-containing chemotherapy as a neoadjuvant…
