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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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Sanofi
NEWS

Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks. Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…
February 2, 2026

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NEWS

Orca Bio Presents New Clinical Data On Orca-Q and Orca-T/CAR-T Combination Therapy at ASH 2025

Shots: Orca Bio reported positive P-I study data for Orca-Q, showing rapid neutrophil recovery, low acute/chronic GvHD, reduced infections, and low non-relapse mortality, including in patients treated without any GvHD prophylaxis Patients receiving Orca-Q with tacrolimus (Arm A, n=18) vs. without immunosuppression (Arm C, n=26) showed comparable survival and GvHD outcomes, with faster neutrophil engraftment…
December 9, 2025

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