non-small cell lung cancer
FDA Approves Hernexeos for Non-Squamous NSCLC with HER2 TKD Activating Mutations
The FDA granted accelerated approval to Hernexeos for some adults with NSCLC.
AUGUST 11, 2025
FDA Grants Accelerated Approval to Datroway for Some Patients With EGFR-Mutated NSCLC
The FDA granted accelerated approval to Datroway for some adults with locally advanced or metastatic EGFR-mutated ...
JUNE 25, 2025
FDA Approves Ibtrozi for ROS1-Positive NSCLC
The FDA approved Ibtrozi, a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive NSCLC.
JUNE 11, 2025
FDA Approves Opdivo Qvantig for Subcutaneous Injection
The FDA approved nivolumab plus hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) for subcutaneous ...
DECEMBER 30, 2024
FDA Approves Ensacove for ALK-Positive Locally Advanced or Metastatic NSCLC
The FDA approved Ensacove for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or ...
DECEMBER 19, 2024
Breathing New Life Into the Lung Cancer Pipeline
The next two years may well see an explosion of FDA approvals for non-small cell lung cancer, with some of the ...
DECEMBER 16, 2024
FDA Grants Accelerated Approval to Bizengri for NSCLC and Pancreatic Adenocarcinoma
The FDA granted accelerated approval to Bizengri for indications in NSCLC and pancreatic adenocarcinoma.
DECEMBER 5, 2024
FDA Approves Neoadjuvant/Adjuvant Opdivo for Resectable NSCLC
The FDA approved Opdivo with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent ...
OCTOBER 4, 2024
Tagrisso Approved for Some With Locally Advanced, Unresectable Stage III NSCLC Following Chemoradiation
The FDA has approved Tagrisso for adult patients with locally advanced, unresectable stage III NSCLC whose disease ...
SEPTEMBER 26, 2024
FDA Approves Rybrevant for NSCLC With EGFR Exon 19 Deletions or L858R Mutations
The FDA has approved Rybrevant with carboplatin and pemetrexed for adult patients with locally advanced or ...
SEPTEMBER 23, 2024
FDA Approves Tecentriq Hybreza for Subcutaneous Injection for All Adult Indications of IV Tecentriq
The FDA has approved Tecentriq Hybreza for subcutaneous injection as the intravenous formulation of Tecentriq.
SEPTEMBER 16, 2024
Rigel Pharmaceuticals Acquires U.S. Rights to Gavreto
Rigel Pharmaceuticals announced that it has entered into a definitive agreement to acquire the U.S. rights to ...
MAY 20, 2024