Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

Shots: Hansoh has reported the P-III (ARTEMIS-008) trial results assessing risvutatug rezetecan (Ris-Rez/HS-20093) vs topotecan in pts with advanced or relapsed SCLC after prior Pt-based therapy Trial met its 1EP of improved OS in the interim analysis, with consistent benefit also observed across 2EPs, incl. PFS; data will be presented at an upcoming conference Based on…

ByRidhi RastogiJuly 10, 2026

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Nanjing Leads Biolabs Receives NMPA Priority Review for Opamtistomig to Treat EP-NEC

Shots: The Chinese NMPA has accepted the BLA & granted priority review to Opamtistomig (LBL-024) as a monotx. for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) BLA was supported by the registrational trial data, designed to assess the efficacy & safety of Opamtistomig in pts with advanced EP-NEC whose disease had progressed following ≥2…

ByRidhi RastogiJuly 10, 2026

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PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Shots: The US FDA has received the BLA of SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) BLA submission follows the P-III (COVER DFUS II) trial assessing SkinTE + SoC vs SoC alone in 120 pts with Wagner 1 DFU, which met its 1EP of complete wound closure SkinTE is a first-in-class autologous…

ByRidhi RastogiJuly 3, 2026

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Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Shots: The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…

ByRidhi RastogiJuly 1, 2026

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Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Shots: The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27 Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which…

ByRidhi RastogiJune 29, 2026

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Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Shots: The NMPA has accepted BLA of Everest's Lerochol (lerodalcibep; SC, QM) as an adjunct to diet & exercise to reduce LDL-C in adults with hypercholesterolemia, incl. heterozygous familial hypercholesterolemia; regulatory review is ongoing in the EU The BLA was supported by multiple global trials & a P-III China study, where in global trials, Lerochol…

ByRidhi RastogiJune 26, 2026

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Inhibrx Biosciences Reports the US FDA’s BLA Acceptance of Ozekibart to Treat Conventional Chondrosarcoma

Shots: The US FDA has accepted BLA of ozekibart (INBRX-109) for the treatment of patients with unresectable or metastatic conventional chondrosarcoma, with no filing review issues identified yet (PDUFA: Apr 14, 2027) BLA was backed by the ChonDRAgon study assessing ozekibart vs PBO in pts with metastatic or unresectable conventional chondrosarcoma, which met its 1EP…

ByRidhi RastogiJune 17, 2026

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Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Shots: The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a…

ByRidhi RastogiJune 8, 2026

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Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Shots: The US FDA has accepted the resubmitted BLA for Xbrane's Lucamzi, a biosimilar to Lucentis, & assigned a BsUFA action date of Oct 29, 2026 The resubmission, completed in Apr 2026, addressed issues identified in the CRL received from the FDA in Oct 2025 The product is already approved & marketed in EU as…

ByRidhi RastogiJune 4, 2026

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Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

Shots: The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept) Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems…

ByRidhi RastogiJune 4, 2026

Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

Nanjing Leads Biolabs Receives NMPA Priority Review for Opamtistomig to Treat EP-NEC

PolarityBio Reports the US FDA BLA Submission of SkinTE for Wagner Grade 1 Diabetic Foot Ulcers

Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease

Everest Medicines Reports NMPA’s BLA Acceptance of Lerochol for Hypercholesterolemia

Inhibrx Biosciences Reports the US FDA’s BLA Acceptance of Ozekibart to Treat Conventional Chondrosarcoma

Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)

Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)

Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)

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