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Merck
NEWS

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 statesApproval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15…
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Fresenius Kabi
NEWS

Fresenius Kabi’s Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) Receives FDA’s Interchangeable Designation

Shots:The US FDA has granted interchangeable designation to Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab), respectively, for the treatment of bone & skeletal disordersConexxence treats adults at high fracture risk, incl. pts with osteoporosis, pts on long-term glucocorticoid therapy or certain cancer treatments affecting bone densityBomyntra prevents SREs in adults with bone-involved malignancies…
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INSIGHTS+

Disease of the Month – Paroxysmal nocturnal hemoglobinuria (PNH) 

Shots: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired blood disorder where the body's immune system attacks and destroys red blood cells and platelets PharmaShots’ Disease of the Month report aims to educate a broad audience about health conditions that affect communities worldwide.  This report provides a comprehensive overview of disease, including its characteristics,…
3 days ago0Comments

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NEWS

Samsung Bioepis Enters Asset Purchase Deal with Biogen for Byooviz (Biosimilar, Lucentis) and Opuviz (Biosimilar, Eylea) in the EU

Shots:Samsung Bioepis has entered an asset purchase agreement with Biogen to acquire its ophthalmology assets, Byooviz & Opuviz, biosimilar versions of Lucentis (ranibizumab) & Eylea (aflibercept), in the EUSamsung Bioepis will assume full responsibility for the commercialization of Byooviz following the transfer of rights from Biogen, effective January 2026Byooviz was approved by…
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NEWS

Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Shots:The US FDA has granted BDD to Avvio ELS for minimally invasive, anesthesia-independent kidney stone treatmentAVVIO ELS will be investigated in a pivotal ELS trial across the US following IDE approval, with US commercial launch planned in 2026, pending FDA clearanceThe AVVIO ELS uses microbubble-enhanced acoustic cavitation lithotripsy to enable minimally invasive kidney…
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Merck new
NEWS

Merck Reports the P-III (LITESPARK-022) Trial Data on Welireg + Keytruda to Treat Clear Cell Renal Cell Carcinoma (RCC)

Shots:Merck has reported the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO) vs Keytruda + PBO for 1yr. in 1,841 pts with clear cell RCC following nephrectomyTrial showed significantly improved disease-free survival (1EP), with OS as 2EP under evaluation; data to be presented in future & shared…
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