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The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion &…
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Viridian & Kissei have entered into an exclusive collaboration & license agreement to develop & commercialize veligrotug & VRDN-003 in Japan
As per the deal, Kissei will secure an…
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The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Trial met its…
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The CHMP has recommended Aqneursa (levacetylleucine) for treating adults & pediatric pts with NPC; additional global submissions are planned for 2025 & beyond
Approval was backed by P-III (IB1001-301)…
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The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.)
Approval was based on P-III (VALIANT) trial assessing Empaveli…
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PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA
The…
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The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision…
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The CHMP has recommended approval of HLX14, a biosimilar version of Amgen’s Prolia/Xgeva (denosumab) for all indications of the reference product; review is ongoing in the US, Canada…
