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)…
Respiratory
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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…
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GSK’s lung cancer therapy gains EMA PRIME designation
GlaxoSmithKline (GSK)’s B7-H3-targeted antibody-drug conjugate (ADC), GSK’227 has gained priority medicines (PRIME) designation from the European Medicines Agency (EMA) for…
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EMA recommends expanding approval of Ofev to children and adolescents
Boehringer Ingelheim has won a positive European Medicines Agency (EMA) recommendation for blockbuster Ofev’s (nintedanib) use in children and adolescents…
