NewAmsterdam Pharma and Menarini receive positive CHMP opinion for Ubeslo and Evlarco
CHMP backs Ubeslo and Evlarco, moving obicetrapib closer to European authorization while PREVAIL tests cardiovascular outcomes.
Pharma & Biotech
Pharma & Biotech
Omeros’ TA-TMA therapy hits European hurdle as regulators question treatment effect
Omeros faces a CHMP refusal for narsoplimab in TA-TMA. Read what the EU re-examination means for evidence, access and launch plans.
Pharma & Biotech
Incyte’s Opzelura wins positive CHMP opinion for moderate atopic dermatitis in Europe
The positive opinion moves ruxolitinib cream closer to a broader European label for adults inadequately controlled by standard topical therapies, opening a potential treatment position between conventional creams and systemic medicines.
Pharma & Biotech
Acadia Pharmaceuticals secures positive CHMP opinion for Daybu in narrowed Rett syndrome indication
Discover why Daybu’s CHMP turnaround could reshape Rett syndrome treatment in Europe and what clinical and access hurdles remain.
Pharma & Biotech
MaaT Pharma seeks second review of MaaT013 as regulators question single-arm evidence
Discover why MaaT Pharma is challenging the negative CHMP opinion on MaaT013 and what the September review means for acute graft-versus-host disease.
Pharma & Biotech
What PolTREG-T1D reveals about the future of cell therapy in autoimmune diseases
PolTREG advances its TREG cell therapy for type 1 diabetes toward EU approval. Learn what this milestone means for autoimmune disease treatment.