The FDA accepted non-invasive Liver Stiffness Measurement as a surrogate endpoint for MASH clinical trials, replacing biopsies. This key decision accelerates MASH drug development by enabling safer monitoring, speeding recruitment, and predicting patient outcomes.
Eli Lilly's orforglipron showed positive results in its second Phase 3 obesity trial, achieving a weight loss of 9.6% at the highest dose. With a consistent safety profile, global regulatory submissions are imminent, aiming for 2026 approval.
Allarity's stenoparib gets FDA Fast Track for advanced ovarian cancer, aiming to expedite development for this serious condition and unmet medical need. A Phase 2 trial is enrolling patients, building on encouraging prior data.
Serina Therapeutics’ SER-252 for advanced Parkinson's gains FDA support for a registrational study via the 505(b)(2) NDA pathway. The POZ Platform enables continuous dopaminergic stimulation, aiming to improve motor fluctuations.
MannKind Corporation acquires scPharmaceuticals, significantly expanding its presence in cardiometabolic medicine with FUROSCIX, an FDA-approved treatment for heart and kidney disease. This strategic move aims to diversify revenue and accelerate growth.
Rocket Pharma's RP-A501 Danon disease trial resumed after FDA lifted hold due to patient death. Shares surged. It will use a lower dose & modified regimen. Signals FDA support for gene therapy despite investor wariness & other patient deaths, like Sarepta's and Neurogene's.
