You are here: Industry Insights > NSCLC

News List

Janssen files EGFR-targeting antibody amivantamab with EMA pharmatimes
January 05, 2021
Janssen, the pharmaceutical division of Johnson & Johnson, has submitted a marketing authorisation application to the European Medicines Agency (EMA) for approval of its epidermal growth factor receptor (EGFR)-targeting bispecific antibody amivantamab.
Pfizer’s Lorbrena scores US priority review pharmatimes
January 05, 2021
Pfizer’s tyrosine kinase inhibitor (TKI) Lorbrena (lorlatinib) has scored a US Food and Drug Administration (FDA) priority review for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).
Amgen Submits Sotorasib Marketing Authorization Application to EMA americanpharmaceuticalreview
December 28, 2020
Amgen announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRASG12C inhibitor, for the treatment of adult patients with previously treated KRAS G12C-mutated ...
Amgen files KRAS inhibitor sotorasib with EMA pharmatimes
December 24, 2020
Amgen has submitted a marketing authorisation application the European Medicines Agency (EMA) for its investigational KRAS inhibitor sotorasib for previously-treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).
Janssen Submits BLA for Metastatic Lung Cancer Treatment americanpharmaceuticalreview
December 24, 2020
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of amivantamab for the treatment of patients with metastatic ...
Green light for AZ’s Tagrisso in early-stage lung cancer pharmatimes
December 22, 2020
The US Food and Drug Administration (FDA) has approved AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patient with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Alunbrig scores NICE backing for ALK-positive lung cancer pharmatimes
December 14, 2020
Takeda’s Alunbrig (brigatinib) has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for patients with ALK-positive advanced non-small cell lung cancer (NSCLC).
EMA Validates Application for Tepotinib for Advanced NSCLC americanpharmaceuticalreview
December 14, 2020
Merck announced the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene ...
Amgen’s sotorasib gets FDA breakthrough therapy status to treat advanced KRAS G12C-mutant NSCLC pharmaceutical-business-review
December 10, 2020
Amgen has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its sotorasib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation.
Janssen eyes US approval for EGFR-targeting NSCLC therapy pharmatimes
December 08, 2020
Janssen has submitted an application the US Food and Drug Administration (FDA) seeking approval for its non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 mutations therapy amivantamab.

Previous page 1 2 3 4 5 6 7 8 9 10 ... 20 21 Next page