DBV Technologies closed 2025 with momentum behind its Viaskin Peanut program, reporting positive phase 3 results in children aged...

Rani Therapeutics has moved its oral biologics platform from promise to clinical testing, initiating a Phase 1 study of...

Spero Therapeutics’ partner GSK has resubmitted the New Drug Application for tebipenem HBr, an oral carbapenem for complicated urinary...

Kyverna Therapeutics is moving to file a BLA in the first half of 2026 for miv-cel (mivocabtagene autoleucel, KYV-101)...

The FDA's approval of a high-dose nusinersen regimen looks like a routine label expansion. Read it as a commercial...

Inhibikase Therapeutics has initiated IMPROVE-PAH, a global, adaptive pivotal Phase 3 program of IKT-001 in pulmonary arterial hypertension, with...

Zenas BioPharma has launched concurrent underwritten offerings of convertible senior notes due 2032 and common stock, including 30-day overallotment...

MoonLake Immunotherapeutics reported Week 40 results from its twin Phase 3 VELA trials of sonelokimab in moderate-to-severe hidradenitis suppurativa,...

Cue Biopharma has appointed Lucinda Warren as interim president and chief executive officer, effective March 26, 2026, following the...

Entera Bio has submitted a streamlined Phase 3 protocol to FDA for EB613, an oral PTH(1-34) anabolic tablet for...