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NEWS

Averoa Receives the MHRA’s Approval for Xoanacyl to Treat Chronic Kidney Disease (CKD)

Shots: The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025 In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…
November 6, 2025

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Merck
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Merck Receives EC’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The EC has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) across all 30 EEA states Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…
October 30, 2025

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Astrazeneca
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AstraZeneca Reports the EC’s Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots: The EC has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1) Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries incl. North America, South America, Europe, Asia &…
October 28, 2025

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Eisai and Biogen Report EU Launch of Leqembi (Lecanemab) to Treat Alzheimer’s Disease
NEWS

Eisai and Biogen Report the Health Canada’s Approval of Leqembi (Lecanemab) to Treat Alzheimer’s Disease

Shots: Health Canada has approved Leqembi with conditions for adults with mild cognitive impairment or mild dementia due to early Alzheimer’s disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology Approval was based on the P-III (Clarity AD) trial assessing Leqembi vs PBO in pts with MCI or mild dementia due to…
October 27, 2025

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Zoetis
NEWS

Zoetis’ Lenivia (Izenivetmab) Receives the CVMP’s Recommendation for Osteoarthritis Pain Relief in Dogs

Shots: The CVMP has recommended Lenivia for the reduction of pain associated with osteoarthritis in dogs, with EC’s decision expected in Q4’25. Also, a commercial launch in the EU is planned for 2026 Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs…
October 13, 2025

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Eli lilly
NEWS

Eli Lilly Reports Kisunla (Donanemab) Approval in the EU to Treat Early Symptomatic Alzheimer’s Disease

Shots: The EC has approved Kisunla to treat early symptomatic Alzheimer’s disease in adults with mild impairment or dementia & confirmed amyloid pathology who are ApoE4 heterozygotes or non-carriers Approval was based on P-III (TRAILBLAZER-ALZ 2) study (n=1736, ≥18mos.) & P-IIIb (TRAILBLAZER-ALZ 6) trial (n=843, 60-85yrs.) assessing Kisunla (QM) vs PBO in AD pts The TRAILBLAZER-ALZ 2 trial showed…
September 26, 2025

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Ionis
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Ionis’ Tryngolza (Olezarsen) Receives the EC’s Approval for Familial Chylomicronemia Syndrome

Shots: The EC has approved Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome Approval was based on P-III (Balance) trial assessing Tryngolza (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute pancreatitis events over 12mos.; data…
September 23, 2025

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Henlius & Organon
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Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…
September 22, 2025

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NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…
September 18, 2025

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NEWS

Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the EC’s Approval for Retinal Diseases

Shots: The EC has approved Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Approval was based on P-III trials conducted across the EU, South Korea, & Japan,…
September 17, 2025

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