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NEWS

Chiesi Reports the EC Approval of Lojuxta to Treat Homozygous Familial Hypercholesterolaemia in Pediatric Patients

Shots: The EC has approved Lojuxta (lomitapide capsules) for the treatment of children (≥5yrs.) with Homozygous Familial Hypercholesterolaemia (HoFH), alongside diet & other lipid-lowering treatments, incl. LDL-apheresis Approval was based on the P-III (APH-19) trial evaluating Lojuxta in 43 pediatric pts (5 to 17yrs.) with HoFH Trial met its 1EP, showing a mean 53.5% reduction…
4 days ago

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NEWS

NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care

Shots: The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26 ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity…
June 1, 2026

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Astrazeneca
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AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…
May 29, 2026

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NEWS

Ironwood Pharmaceuticals Reports the US FDA Approval of Linzess to Treat Pediatric Patients (≥2yrs.) with Functional Constipation

Shots: The US FDA has approved label expansion of Linzess (linaclotide) in pts (≥2yrs.) for the treatment of functional constipation (FC) Approval was supported by data from a 12wk. P-III trial assessing Linzess in pediatric pts (2-5yrs.) with FC, where Linzess (72mcg) showed improvement in spontaneous bowel movement frequency vs PBO Linzess contains linaclotide, a…
May 28, 2026

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Abbvie
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AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Shots: The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease  Trial reported a 69.7% composite…
May 28, 2026

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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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