If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations
The trial targeted a patient population with high BMI and extensive skin involvement, averaging over 39 kg/m²
BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC
The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission
The trial, which compared Retevmo to placebo, met its primary endpoint with a “highly statistically significant and clinically meaningful improvement” in investigator-assessed EFS for patients with stage II–IIIA disease
Duvakitug was well tolerated and safety was consistent with the induction study
mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe
Iberdomide has the potential to be the first approved CELMoD agent
The approval marks a major advance in targeted treatment for this rare, chronic autoimmune disease, offering twice-yearly maintenance dosing after two initial loading doses
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.”
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