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…
Respiratory
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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…
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Meitheal gains US commercial rights for CABP treatment therapy
Meitheal Pharmaceuticals has gained exclusive US commercial rights for a first-in-class semi-synthetic pleuromutilin antibiotic, XENLETA (lefamulin acetate), to treat community-acquired…
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FDA to review GSK’s Nucala for COPD
The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala…
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FDA approves AstraZeneca’s Imfinzi to treat LS-SCLC
The US Food and Drug Administration (FDA) has approved AstraZeneca's human monoclonal antibody, Imfinzi (durvalumab), to treat limited-stage small cell…
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GSK gains approval in Japan for extended indication of RSV vaccine
GlaxoSmithKline (GSK) has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for its regulatory application to extend…
