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Sanofi
NEWS

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…
5 days ago

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Arrowhead Pharmaceuticals
NEWS

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26  Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…
April 24, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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NEWS

Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Shots: The CHMP has recommended Joenja for the treatment of pts (≥12yrs.) with APDS syndrome, with EC decision expected in Q2’26, which, if positive, would be valid across all 30 EEA member states Opinion was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12 years), showing significant improvement in immune dysregulation…
March 30, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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NEWS

X4 Pharmaceuticals’ Xolremdi (Mavorixafor) Receives the CHMP Positive Opinion for WHIM Syndrome

Shots: The CHMP has recommended approval of Xolremdi, under exceptional circumstances, for the treatment of WHIM syndrome, with EC’s decision expected in Q2’26 Opinion was backed by the global P-III (4WHIM) trial assessing Xolremdi vs PBO in 31 pts (≥12yrs.) with WHIM syndrome, which showed improved absolute lymphocyte counts, absolute neutrophil counts, & fewer infections,…
March 2, 2026

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Ipsen Pharmaceuticals
NEWS

Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

Shots: The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG…
March 2, 2026

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NEWS

Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid) 

Shots:  The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and  NovoRapid, respectively, across all 30 EEA states  Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.  Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz…
February 27, 2026

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