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argenx has reported topline P-III (ADAPT SERON) trial data on Vyvgart (efgartigimod alfa; IV) for AChR-Ab seronegative generalized myasthenia gravis (gMG)
Trial (n=119) consist of 2 Parts: Part A…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, and Biosimilars. Check out our full report below:
HUTCHMED Completes Patient Enrolment in P-III (SANOVO)…
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Tyra Biosciences has dosed its first patient with dabogratinib (FGFR3 inhibitor) in P-II (BEACH301) trial for the treatment achondroplasia
Trial will evaluate dabogratinib in children (3–10 yrs) with achondroplasia…
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The US FDA has granted 510(k) clearance to the Salix Coronary Plaque module for the detection & quantification of coronary artery plaque; Salix is available since Jul 2025 in the…
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Health Canada has approved Columvi + GemOx for the treatment of ASCT-ineligible pts with r/r diffuse large b-cell lymphoma (DLBCL)
Approval was based on P-III (STARGLO) study of Columvi…
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Health Canada has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts
Approval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT…
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AbbVie has reported topline P-III (UP-AA) trial data on Rinvoq (QD) for sev. alopecia areata in pts with a mean baseline SALT score of 84
Trial incl. 2 replicate…
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The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days…
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Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being
The global Top 20…