Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program Study A & C (N=284) assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg…

ByRidhi RastogiNovember 25, 2025

NEWS

Novartis’ Itvisma Receives the US FDA Approval for Spinal Muscular Atrophy

Shots: The US FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of pts (≥2yrs.) living with spinal muscular atrophy (SMA) harboring a confirmed mutation in the SMN1 gene; US availability expected in Dec 2025 Approval was based on the P-III (STEER) trial & open-label P-IIIb (STRENGTH) study, showing Itvisma improved motor function & stabilized…

ByRidhi RastogiNovember 25, 2025

NEWS

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Shots: The EC has approved Breyanzi (lisocabtagene maraleucel) for the treatment of adults with r/r mantle cell lymphoma (MCL) after ≥2L of systemic therapy, incl. a BTK inhibitor, in all 30 EEA states Approval was based on the MCL cohort of the P-I (TRANSCEND NHL 001) trial assessing Breyanzi in adults with r/r B-cell non-Hodgkin…

ByRidhi RastogiNovember 25, 2025

NEWS

Alvotech Reports the EC Approval of AVT03 (Biosimilar, Prolia and Xgeva)

Shots: The EC has approved AVT03, a biosimilar version of Amgen’s Prolia & Xgeva (denosumab), in 60mg/mL PFS (Prolia) & 70mg/mL single-use vial (Xgeva) presentation Approval was based on extensive clinical data, incl. analytical, PK & PD data, plus data from AVT03-GL-C01 trial (vs Prolia) among postmenopausal women with osteoporosis, as well as AVT03-GL-P01 trial (vs…

ByRidhi RastogiNovember 24, 2025

NEWS

Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: FDA has approved Padcev (enfortumab vedotin-ejfv) + Keytruda or Keytruda Qlex for neoadj. & adj. treatment for cisplatin-ineligible pts with MIBC, before the PDUFA action date (Apr 07, 2026) Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B…

ByRidhi RastogiNovember 24, 2025

NEWS

AstraZeneca Reports the US FDA Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Shots: The US FDA 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 RastogiNovember 20, 2025

NEWS

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

Shots: The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W;…

ByRidhi RastogiNovember 20, 2025

NEWS

Bayer Reports the EC Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Shots: The EC has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause or caused by adj. endocrine therapy related to breast cancer; regulatory filings are ongoing in other regions Approval was based on P-III (OASIS) program assessing Lynkuet (120mg, QD, PO), which consists of OASIS-1 (n=396), OASIS-2 (n=400) &…

ByRidhi RastogiNovember 20, 2025

NEWS

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: The US FDA 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 clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab In 2022,…

ByRidhi RastogiNovember 19, 2025

NEWS

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026 Approval was based on extensive clinical data, incl. P-III (ASPEN)…

ByRidhi RastogiNovember 19, 2025

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Novartis’ Itvisma Receives the US FDA Approval for Spinal Muscular Atrophy

BMS’ Breyanzi Receives the EC Approval to Treat R/R Mantle Cell Lymphoma

Alvotech Reports the EC Approval of AVT03 (Biosimilar, Prolia and Xgeva)

Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

AstraZeneca Reports the US FDA Approval of Koselugo (Selumetinib) for Treating Neurofibromatosis Type 1

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

Bayer Reports the EC Approval of Lynkuet (Elinzanetant) to Treat Vasomotor Symptoms

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

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