Sarepta Therapeutics says the FDA has agreed to review a regulatory package for Amondys 45 and Vyondys 53 after they failed a confirmatory trial, but whether the agency will agree to approve them is ...
Dyne Therapeutics (NASDAQ:DYN) executives outlined a slate of 2026 operational and regulatory milestones during a discussion ...
Dyne Therapeutics is plotting an approval application for z-rostudirsen in the back half of 2026—a push that will only be bolstered by the departure of controversial CBER chief Vinay Prasad, according ...
Results showed a statistically significant improvement in progression free survival in patients treated with amivantamab with carboplatin + pemetrexed compared with those who received carboplatin + ...
Management of patients with ALK-positive advanced non-small cell lung cancer who received brain radiotherapy on study in the phase 3 CROWN trial. First results from the RETgistry: A global consortium ...
There are promising developments in the pipeline for EGFR exon 20 insertion–positive non–small cell lung cancer (NSCLC), and groups like The Exon 20 Group can help ensure patients are getting access ...
A new study describes the structure of a crucial enzyme present in the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is the virus responsible for coronavirus disease 2019 ...
The FDA granted accelerated approval to the tyrosine kinase inhibitor sunvozertinib (Zegfrovy) for advanced non-small cell lung cancer (NSCLC) associated with EGFR exon 20 insertions, the agency said.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results