Clinical Trials Arena

FDA reversal on mRNA-1010 could transform the seasonal influenza vaccines market

Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010.
Clinical Trials Arena

C4 Therapeutics doses first patient in MOMENTUM trial for multiple myeloma

C4 Therapeutics has dosed the first patient in its Phase II MOMENTUM trial of cemsidomide, an oral IKZF1/3 degrader, combined with dexamethasone for patients with RRMM.
Clinical Trials Arena

HIV patients show lower steatotic liver disease with ViiV’s Dovato vs Biktarvy

Patients with HIV showed lower cases of steatotic liver disease when switched to ViiV Healthcare’s Dovato compared to ...
Clinical Trials Arena

Gene editing takes centre stage in FDA’s new rare disease approval pathway

The US Food and Drug Administration (FDA) has issued more information to sponsors regarding its “plausible mechanism pathway” ...
Clinical Trials Arena

Novo Nordisk’s CagriSema bested by Lilly’s Zepbound in head-to-head trial

In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema ...
Clinical Trials Arena

Gossamer Bio reports topline Phase III PROSERA outcomes for PAH

Gossamer Bio has reported topline data from the Phase III PROSERA study evaluating seralutinib in patients with PAH.
Clinical Trials Arena

Compass stock heads north on psychedelic’s Phase III TRD success

Compass will now seek approval for COMP360 in TRD, which could become the first classic psychedelic to gain the FDA’s ...
Clinical Trials Arena

Patient enrolment concludes in Senti Biosciences’ SENTI-202 Phase I trial

Senti Biosciences has completed enrolment of patients in its Phase I clinical trial assessing SENTI-202 in adults with ...
Clinical Trials Arena

First patient recruited in North Midlands CRDC’s stroke trial

The North Midlands CRDC has recruited its first patient, representing the UK’s initial participation in a clinical trial of ...
Clinical Trials Arena

FDA to allow one pivotal trial instead of two for drug approval

Prasad and Makary disagree that some may believe this move to just one pivotal trial shows the FDA relaxing its standards.
Clinical Trials Arena

Roche eyes Gazyva label expansion on positive Phase III kidney disease data

Roche's Gazyva could become the first drug to gain approval in membranous nephropathy, pending regulatory decisions from the ...
Clinical Trials Arena

Second Pfizer Braftovi regimen shows benefit in mCRC

Another of Pfizer’s Braftovi regimens has shown benefit in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.