RAHWAY, N.J. — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with...
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Barcelona, Spain and Düsseldorf, Germany – Neuraxpharm Group and Minoryx Therapeutics, today announce that the European Commission (EC) has granted marketing authorisation under exceptional circumstances for NEZGLYAL® (leriglitazone), an orally bioavailable, brain penetrating, selective PPAR gamma agonist, as a treatment for male cALD patients, aged 2-12 years with Gadolinium (Gd)-negative...
Basel, Switzerland – Novartis today announced that the European Commission (EC) has approved Itvisma® (onasemnogene abeparvovec) for the treatment of children two years and older, teens and adults living with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. With this approval, Itvisma...
NEW YORK, NY — Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response,...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. These disease classifications describe the...
Basel, Switzerland – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional marketing authorisation of Lunsumio® (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Approval is based...
Basel, Switzerland – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Commission has approved Susvimo® (ranibizumab 100 mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), a leading cause of vision loss in people over the age of 60.5,6 “The European Commission approval...
BOSTON, Mass. — Servier, an independent international pharmaceutical group governed by a foundation, today announced that the European Commission (EC) has approved VORANIGO® (vorasidenib) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent...
Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation1 European Commission (EC) approval based on positive results from the Phase 3 PALOMA-3 study1 BEERSE, Belgium — Janssen-Cilag International NV, a Johnson &...
SAN CARLOS, Calif. — BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung...