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Astrazeneca

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 ×…

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Top 20 Prescription Drugs of 2025 

Shots:  In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…

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Astrazeneca

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…

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Daiichi Sankyo

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC

Shots: Daiichi Sankyo has dosed the first patient with Enhertu in combination with Keytruda in the P-III (DESTINYLung06) trial as a 1L treatment for unresectable, LA/M HER2 overexpressing & PD-L1 (TPS<50%) non-squamous NSCLC Trial will assess Enhertu (5.4mg/kg) + Keytruda vs Keytruda + Pt-based CT + pemetrexed as the 1L treatment in the mentioned pts…

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Daiichi Sankyo

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…

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Astrazeneca

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 &…

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AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countries Approval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…

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