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NEWS

Agios Reports the EC Approval of Pyrukynd for Anemia in Alpha or Beta Thalassemia

Shots: The EC has approved Agios’ Pyrukynd(mitapivat), marketed as Aqvesme in the US, for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies assessing Pyrukynd (100mg, BID) vs PBO in 194 on-transfusion-dependent pts and 258 transfusion-dependent pts, respectively Pyrukynd will be…
May 25, 2026

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NEWS

Pharming Reports the EC approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

Shots: The EC has approved Joenja for pts (≥12yrs.) with APDS syndrome across all 30 EEA states. Initial launch is expected in Germany in Q3’26, with further launches anticipated subject to completion of national reimbursement negotiations Approval was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12yrs.), showing significant improvement in…
May 25, 2026

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Astrazeneca & Daiichi Sankyo
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Daiichi Sankyo and AstraZeneca Report the US FDA Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: The US FDA has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy Approval was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in mOS & 43% reduction in disease…
May 25, 2026

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GSK
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GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…
May 19, 2026

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NEWS

Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)

Shots: The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…
May 19, 2026

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sandoz
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Sandoz Reports the EC Approval of Bysumlog and Dazparda (Biosimilars, Humalog and NovoRapid)

Shots: The EC has approved Bysumlog & Dazparda, the biosimilar versions of Humalog (insulin lispro) & NovoRapid (insulin aspart), respectively, as prefilled pens Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults & children, while Dazparda is approved for diabetes treatment in pts (≥1yr.). Both demonstrated equivalent efficacy & comparable…
May 18, 2026

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Astrazeneca
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AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension  Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension  Trial met…
May 18, 2026

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NEWS

Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…
May 18, 2026

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Astrazeneca & Daiichi Sankyo
NEWS

AstraZeneca and Daiichi Sankyo’s Enhertu Receives US FDA Approval in Early Breast Cancer for Two Indications

Shots: FDA has approved Enhertu + THP for neoadj. treatment of adults with HER2+ Stage II/III breast cancer, & Enhertu monotx. for adj. treatment in adults with residual invasive disease post Herceptin (± Perjeta) & taxane-based therapy, triggering a $155M milestone payment from AZ to Daiichi Sankyo For neoadj. setting, approval was backed by DESTINY-Breast11…
May 18, 2026

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Astrazeneca
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AstraZeneca’s Fasenra Receives the US FDA Approval for Hypereosinophilic Syndrome

Shots: The US FDA has approved AstraZeneca's Fasenra (benralizumab) for the treatment of pts (≥12yrs.) with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause Approval was based on the 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…
May 15, 2026

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