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Alto Neuroscience completes enrollment in Phase 2 trial for first-of-its-kind schizophrenia cognitive treatment
Clinical Trials | February 17, 2026

Alto Neuroscience completes enrollment in Phase 2 trial for first-of-its-kind schizophrenia cognitive treatment

Alto met its enrollment goal with 83 patients across 13 US clinical sites


HanchorBio scores first FDA orphan drug tag for gastric cancer therapy
Biotech | February 17, 2026

HanchorBio scores first FDA orphan drug tag for gastric cancer therapy

The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients


Beyfortus cuts RSV hospitalizations across two seasons in landmark study
News | February 17, 2026

Beyfortus cuts RSV hospitalizations across two seasons in landmark study

The NIRSE-GAL study, conducted in Galicia, Spain, is the first real-world, population-based investigation of a universal RSV immunization program spanning two consecutive seasons


EU to withdraw Levamisole medicines over risk of rare, deadly brain disorder
News | February 17, 2026

EU to withdraw Levamisole medicines over risk of rare, deadly brain disorder

The recommendation is based on new data from continuous safety monitoring of medicines in the EU


Moderna’s new Covid vaccine mNEXSPIKE wins European approval
News | February 17, 2026

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe


Roche appoints Mark Dawson as new Head of Pharma Research and Early Development
People | February 17, 2026

Roche appoints Mark Dawson as new Head of Pharma Research and Early Development

Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research


Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough
Drug Approval | February 16, 2026

Biofrontera scores FDA filing acceptance for Ameluz PDT in skin cancer breakthrough

If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US


STADA & Bio-Thera bag European nod for Gotenfia
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia


FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue
Drug Approval | February 14, 2026

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”