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,…

ByRidhi RastogiNovember 6, 2025

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UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Shots: FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA's review, with additional regulatory filings planned Approval was backed by a P-II trial, 2 retrospective chart review studies, & an…

ByRidhi RastogiNovember 4, 2025

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Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

Shots: Health Canada has approved Enhertu monotx. for adult with inoperable HR+, HER2-low/ultralow MBC who have received ≥1 endocrine therapy (ET) & are ineligible for ET as the next line of therapy Approval was based on the P-III (DESTINY-Breast06) trial (N=866) assessing Enhertu (5.4mg/kg) vs CT (capecitabine/paclitaxel/nab-paclitaxel) in HR+, HER2-low (n=713) & ultralow (n=152) pts Trial showed improved PFS…

ByRidhi RastogiOctober 31, 2025

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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…

ByRidhi RastogiOctober 30, 2025

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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 &…

ByRidhi RastogiOctober 28, 2025

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Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Shots: The US FDA has approved label expansion of Revuforj to treat pts (≥1yrs.) with nucleophosmin 1 (NPM1)-mutated r/r acute myeloid leukemia (AML) who have no satisfactory alternative treatment options Approval was supported by P-II results from the P-I/II (AUGMENT-101) trial, which showed a 23% CR + CRh rate (15/65), median response time of 2.8mos.,…

ByRidhi RastogiOctober 28, 2025

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Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Shots: The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026 Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…

ByDipanshu DixitOctober 28, 2025

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Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots: The US FDA has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause based on P-III (OASIS-1, 2, & 3) trials, with commercial availability expected at the start of Nov 2025; MAA is under the EMA’s review Efficacy was evaluated in OASIS-1 & 2 trials assessing Lynkuet vs PBO…

ByRidhi RastogiOctober 27, 2025

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Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

Shots: The NMPA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in Japan & the EU, with further filings planned Approval was based on P-III (FIBRONEER-IPF) assessing Jascayd (18 or 9mg, PO, BID) vs PBO in IPF pts, which met its 1EP of reduced FVC decline at…

ByRidhi RastogiOctober 24, 2025

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GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

Shots: The US FDA has approved Blenrep + BorDex for the treatment of r/r MM in adults who have received ≥1 prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent. NDA under NMPA’s priority review Approval was based on P-III (DREAMM-7) trial assessing Blenrep (2.5mg/kg, IV, Q3W) in combination with BorDex for 8 cycles, then as a single…

ByRidhi RastogiOctober 24, 2025

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

UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)

Daiichi Sankyo Reports the Health Canada’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC)

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

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

Syndax Pharmaceuticals’ Revuforj (Revumenib) Receives the US FDA’s Approval for NPM1-Mutated R/R Acute Myeloid Leukemia

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Bayer Reports the US FDA’s Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Boehringer Ingelheim Reports the NMPA’s Approval of Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

GSK’s Blenrep (Belantamab Mafodotin) Regimen Receives the US FDA’s Approval to Treat R/R Multiple Myeloma

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