AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES)

Shots: AstraZeneca has reported P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks. Trial met its 1EP of delayed time to first HES worsening or flare & reduced the risk of HES worsening/flare by 65% Trial met all 2EPs, showing…

ByRidhi RastogiNovember 10, 2025

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Shots: FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fihj) for high‑risk SMM based on the P-III (AQUILA) study assessing Darzalex Faspro alone vs active monitoring in adults, which met its 1EP of improved PFS by 51%, with 63.1% vs 40.7% pts progression-free at a mFU of 65.2mos. Trial also showed an improved ORR (63.4% vs…

ByRidhi RastogiNovember 7, 2025

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

Shots: FDA has approved Wayrilz for adults with persistent or chronic ITP who did not respond adequately to prior therapy following approval in UAE in Jun 2025; Application under the EMA & NMPA's review Approval was based on P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO in adults (n=202) with ITP over…

ByRidhi RastogiSeptember 1, 2025

AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES)

Johnson & Johnson’s Darzalex Faspro Secures the US FDA’s Approval for High-Risk Smouldering Multiple Myeloma (SMM)

Sanofi’s Wayrilz (Rilzabrutinib) Receives the US FDA’s Approval for Immune Thrombocytopenia (ITP)

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