Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.
MRM Health has received clearance from the FDA for its IND application, enabling the company to start the STARFISH-UC Phase ...
GSK will be filing for approval of bepirovirsen in hepatitis B to global regulatory authorities based on the Phase III data.
The Mount Sinai TCC has introduced an AI clinical trial matching platform, PRISM, to improve access to cancer research ...
In the Phase Ib JADE trial, OLN324 demonstrated both faster and greater retinal drying versus Vabysmo in patients with DME, ...
NRG Therapeutics has dosed the first participants in its Phase I clinical trial of NRG5051, being developed as a ...
In the ongoing study (NCT06700538), Arrowhead’s candidate, called ARO-INHBE, plus Zepbound, doubled weight loss and tripled ...
Neumora Therapeutics’ oral Alzheimer’s disease agitation drug has shown benefit, reducing agitation, in a Phase Ib trial.
Treatment with the tumour necrosis factor receptor 2 (TNFR2)-targeting monoclonal antibody (mAb) plus Keytruda was also found ...
While obexelimab failed to best Uplizna in terms of efficacy, Zenas will still file for the drug’s approval in IgG4-RD.
The MHRA will implement a 14-day assessment process for phase I trials to expedite early new medicine testing. Credit: Wasan Tita / Shutterstock.com. The UK has announced new clinical trial regulatory ...
MetaVia will now be investigating the candidate at two different titration levels in 16-week trials for obesity.
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