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GSK
NEWS

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…
15 hours ago

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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…
20 hours ago

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sandoz
NEWS

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…
2 days ago

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Astrazeneca
NEWS

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…
2 days ago

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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…
2 days ago

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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…
2 days ago

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NEWS

Taiho Oncology (Part of Taiho Pharmaceutical) Reports the US FDA Approval of Inqovi + Venetoclax for Newly Diagnosed AML

Shots: The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT Trial showed a…
May 14, 2026

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NEWS

Partner Therapeutics Reports the US FDA Approval of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The FDA has approved Partner Therapeutics' Bizengri (zenocutuzumab-zbco) under CNPV, for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion who progressed on or after prior systemic therapy Approval was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive advanced solid tumors, incl. cholangiocarcinoma (n=22, where 19 were…
May 11, 2026

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