Phase 2
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
The FDA has a very busy week ending the month of March and moving into April, highlighted by a big AdCom vote on Amylyx’s ALS candidate AMX0035 on March 30.
Seattle-based Icosavax’s stock plunged 50% after the company reported topline interim data from its ongoing Phase I/II COVID-19 vaccine trial.
Novavax announced today that its protein-based Covid-19 vaccine, NVX-CoV2373, is included in two new clinical trials that will evaluate the vaccine as a potential Covid booster.
Although it was relatively quiet in COVID-19-related clinical trials, there was plenty of other clinical trial news. Here’s a look.
The FDA recommends a randomized trial to adequately assess drug efficacy and safety of P13K inhibitor drug candidates.
The FDA delayed Bristol Myers Squibb’s (BMS) target date for Reblozyl, approved the company’s melanoma drug and Japan accepted BMS’ NDA for Breyanzi.
The Phase II trial is evaluating zepzelca as a monotherapy in patients with urothelial carcinoma, large cell neuroendocrine carcinoma of the lung and HRD tumors.
BioAge Labs presented new data demonstrating how its drug candidate BGE-175 is uniquely poised to tackle age-related immune system decline that leads to disease progression.
The 4D pharma has shared positive interim results from its Phase I/II study of a combination therapeutic for the treatment of renal cell carcinoma (RCC).
PRESS RELEASES