What FDA’s latest ibezapolstat guidance means for Acurx and the IBZ-ASPIRE trial
FDA feedback may let Acurx use one Phase 3 ibezapolstat trial for C. difficile treatment and recurrence, but evidence and funding remain decisive.
FDA feedback may let Acurx use one Phase 3 ibezapolstat trial for C. difficile treatment and recurrence, but evidence and funding remain decisive.
Galmed’s Aramchol film may simplify Parkinson’s dosing, but clinical proof and regulatory clearance remain ahead. See what matters next.
Novanta completes Riverpoint Medical acquisition, expanding surgical consumables and recurring revenue. See what integration and returns must deliver.
argenx is buying Forte Biosciences for $2.2bn to secure FB102. See why early vitiligo and celiac data make Phase 2 execution decisive.
Apnimed, Inc. has filed for an initial public offering in the United States as it prepares for a potentially decisive regulatory year for AD109, its once-nightly oral treatment for obstructive sleep apnea. The Cambridge, Massachusetts-based pharmaceutical company plans to list on the Nasdaq Global Market under the ticker APMD, although the number of shares, proposed
Find out how Compass Pathways’ COMP360 Phase 3 data could shape regulated psilocybin treatment for depression.
Find out how UroGen Pharma’s UGN-501 could test oncolytic virus therapy for recurrent non-muscle invasive bladder cancer.
Find out how Gain Therapeutics’ GT-02287 could test GCase restoration as a disease-modifying strategy for Parkinson’s disease.
Find out how QT Imaging’s clean FDA inspection could support Breast Acoustic CT scale-up and breast imaging adoption.
Find out how Parabilis Medicines’ IPO surge could reshape investor appetite for Helicon peptides and Wnt-driven oncology drugs.