The Food and Drug Administration (“FDA”) said on Thursday that they will seek to pull the common ingredient phenylephrine off ...
This gathering came shortly after the FDA’s decision to decline Lykos Therapeutics' application for midomafetamine ...
Company and Agency aligned on key efficacy and safety measures to be studied in Phase 3 programPivotal Phase 3 trials designed to leverage the ...
Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...
NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) on Monday said it is scheduled for an FDA Type C meeting to discuss the design of ...
On October 28, 2024, the Foundation for Sarcoidosis Research (FSR) hosted a groundbreaking Externally Led Patient-Focused ...
Pharmaceuticals’ New Drug Application #210934, for sotagliflozin oral tablet, as an adjunct to insulin therapy, to improve ...
The FDA recently approved a phase 2 clinical trial to investigate the efficacy of leronlimab in patients with relapsed or ...
The FDA Type C meeting, scheduled for November 6, 2024, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also ...
There are several forms of communications FDA may send to signify an issue. FDA may send a company a notice of a violation in ...
Obe-cel was designed to increase T-cell persistence and reduce T-cell exhaustion and was shown to improve response rates and survival, particularly in patients with low leukemia burden.