Seres Therapeutics Implements Cost Cuts After FDA Feedback
Seres’ SER-155 previously showed a 77% relative reduction in bloodstream infections versus placebo in a Phase 1b allo-HSCT study,...
BPL-003 Trial Shows Victory for Treatment-Resistant Depression
In an open-label Phase 2a study of 13 patients with treatment-resistant depression, intranasal mebufotenin benzoate (BPL-003) delivered a mean...
Actuate Gives FDA Updated Clinical Data for EMA Interactions
Actuate’s randomized Phase 2 (n=286) in first-line metastatic pancreatic adenocarcinoma reported a statistically significant improvement in median overall survival...
Cytisinicline Shows Potential for Smoking Cessation in COPD
Cytisinicline increased continuous smoking abstinence versus placebo with statistical significance in both COPD and non-COPD subgroups across the Phase...
New Hope for Neuropathic Corneal Pain: A Urcosimod Trial
In a randomized, double-masked, placebo-controlled Phase 2 proof-of-concept study of 17 patients with neuropathic corneal pain (NCP), 75% of...
New Vitiligo Therapy Shows Unprecedented Response Rates
A 251-patient, multicenter randomized controlled trial in adults with localized non-segmental vitiligo reported that combining a 308 nm excimer...
Cerevance to Present Phase 2 Data on Solengepras in Parkinson’s
Phase 2 data from the ASCEND trial of solengepras signaled potential benefit on functional and non-motor measures in early...
Adverum Finishes Screening for Pivotal ARTEMIS Wet AMD Trial
Screening for Adverum’s first Phase 3 trial of its intravitreal gene therapy for wet AMD will close by September...
FDA’s National Priority Voucher Program Is Just a Modular PMA Rebrand, With Risks
In June 2025, FDA announced its new Commissioner’s National Priority Voucher (CNPV) program, a headline-grabbing reform that promises to...
C4’s Cemsidomide Data Supports Best-in-Class Myeloma Drug
C4 Therapeutics reported a 50% overall response rate at 100 µg and 40% at 75 µg for cemsidomide plus...