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NEWS

Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Shots: The EC has approved Agios’ Pyrukynd(mitapivat), marketed as Aqvesme in the US, for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies assessing Pyrukynd (100mg, BID) vs PBO in 194 on-transfusion-dependent pts and 258 transfusion-dependent pts, respectively Pyrukynd will be…
May 25, 2026

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NEWS

Pharming Reports the EC approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

Shots: The EC has approved Joenja for pts (≥12yrs.) with APDS syndrome across all 30 EEA states. Initial launch is expected in Germany in Q3’26, with further launches anticipated subject to completion of national reimbursement negotiations Approval was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12yrs.), showing significant improvement in…
May 25, 2026

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sandoz
NEWS

Sandoz Reports the EC Approval of Bysumlog and Dazparda (Biosimilars, Humalog and NovoRapid)

Shots: The EC has approved Bysumlog & Dazparda, the biosimilar versions of Humalog (insulin lispro) & NovoRapid (insulin aspart), respectively, as prefilled pens Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults & children, while Dazparda is approved for diabetes treatment in pts (≥1yr.). Both demonstrated equivalent efficacy & comparable…
May 18, 2026

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BMS
NEWS

BMS’ Sotyktu (Deucravacitinib) Wins EC Approval to Treat Adults with Active Psoriatic Arthritis (PsA)

Shots: FDA has approved BMS' Sotyktu (6mg, PO, QD) ± methotrexate for adults with active PsA who have had an inadequate response or were intolerant to a prior disease-modifying antirheumatic (DMARD) therapy Approval was based on P-III trials, incl. POETYK PsA-1, involving 670 bDMARD-naïve pts, and POETYK PsA-2, involving 624 pts who were bDMARD-naïve &…
May 11, 2026

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Rhythm Pharmaceuticals
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Rhythm Pharmaceuticals Reports the EC Approval of Imcivree (Setmelanotide) for Acquired Hypothalamic Obesity

Shots: The EC has approved label expansion of Imcivree to incl. treatment of obesity & control of hunger in pts (≥4yrs.) with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment; commercial launch is expected in 2027 Approval was supported 120-patient cohort data from the global P-III (TRANSCEND) trial assessing setmelanotide (n=81) vs PBO…
May 4, 2026

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Henlius & Organon
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Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots: The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
April 30, 2026

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Ipsen Pharmaceuticals
NEWS

Ipsen’s Ojemda (Tovorafenib) Receives Conditional Approval for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG) in the EU

Shots: The EC has granted conditional approval to Ipsen's Ojemda as a 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, across all 30 EEA states Approval was based on the P-II (FIREFLY-1) trial assessing Ojemda (QW, PO)…
April 22, 2026

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