BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Shots: The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across…

ByRidhi RastogiNovember 26, 2025

NEWS

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Shots: FDA has approved perioperative Imfinzi for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, with submission reviewed under Project Orbis & based on P-III (MATTERHORN) trial; regulatory review is ongoing in the EU & Japan In the trial, Pts (n=948) received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W ×…

ByRidhi RastogiNovember 26, 2025

NEWS

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

Shots: The US FDA has granted accelerated approval to Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary IgAN at risk for disease progression Approval was based on the interim data from the ongoing P-III (VISIONARY) trial, assessing Voyxact (400mg, SC, Q4W) vs PBO in 510 IgAN adults, who were on SoC therapy Trial…

ByRidhi RastogiNovember 26, 2025

NEWS

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

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

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for Advanced HER2-mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hyrnuo (BAY 2927088; reversible TKI) under priority review for the treatment of previously treated pts with LA/M NSCLC harboring HER2 tyrosine kinase domain activating mutations; NDA under NMPA’s review Approval was based on the ORR & DoR data from the ongoing P-I/II (SOHO-01) trial assessing Hyrnuo (PO) in…

ByRidhi RastogiNovember 21, 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

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

AstraZeneca Secures the US FDA Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

Otsuka Pharmaceutical Receives the US FDA Accelerated Approval for Primary Immunoglobulin A Nephropathy (IgAN)

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

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

Bayer’s Hyrnuo (Sevabertinib) Gains the US FDA Accelerated Approval for Advanced HER2-mutant NSCLC

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

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