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NEWS

AbelZeta Gains FDA IND Clearance for Bispecific CAR-T C-CAR039 in LBCL

Shots: AbelZeta has received FDA clearance for the IND application for C-CAR039 (prizloncabtagene autoleucel), an anti-CD20/CD19 bispecific CAR-T therapy, for r/r large B-cell lymphoma (LBCL) AbelZeta regained global development, regulatory, manufacturing, & commercialization rights to C-CAR039 in Jul 2026 & is working with the FDA to finalize clinical protocols for 3L or later LBCL pts…
August 18, 2026

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NEWS

Rigel Reports Availability of Veppanu for ER+/HER2-, ESR1-Mutated Breast Cancer

Shots: Rigel has reported the availability of Veppanu (vepdegestrant) by prescription in the US for the treatment of adults with ER+/ HER2-, ESR1-mutated advanced or metastatic breast cancer, with disease progression following ≥1L of endocrine therapy Veppanu (200mg, PO, QD) is an FDA-approved PROTAC, a class of targeted protein degraders that uses the body’s natural machinery to…
August 14, 2026

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ArkBio
NEWS

ArkBio’s Ziresovir Secures the US FDA Approval for P-II Trial in RSV Infant Patients

Shots: The US FDA has approved ziresovir (AK0529) for a P-II trial in the severely ill RSV infected infant patients, including those in the pediatric intensive care unit (PICU) The trial will compare ziresovir with PBO to evaluate clinical efficacy, particularly oxygen-treatment duration & sustained recovery time, generating data to support future registrational trials In…
August 14, 2026

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Zoetis
NEWS

Zoetis’ Simparica Trio Receives FDA’s EUA for Treating New World Screwworm Infestations in Dogs and Puppies

Shots: The US FDA has granted Emergency Use Authorization (EUA) to Simparica Trio (sarolaner, moxidectin, and pyrantel chewable tablets)for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) in dogs & puppies Simparica Trio is an all-in-one monthly chewable for dogs, providing protection against heartworm disease, ticks, fleas, roundworms, & hookworms,…
August 14, 2026

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NEWS

Vesalio Receives FDA 510(k) Clearance for pVasc NET Peripheral Thrombectomy Device

Shots: Vesalio has received the US FDA 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device with an integrated distal filter  pVasc NET builds on the pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter for non-surgical removal of emboli & thrombi from peripheral blood vessels pVasc NET features a fine-pore,…
August 14, 2026

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BMS
NEWS

BMS Reports the US FDA Accelerated Approval for Zenbexus (Iberdomide) Combination in R/R Multiple Myeloma (MM)

Shots: FDA has granted accelerated approval to Zenbexus (iberdomide) + daratumumab & hyaluronidase-fihj + dexamethasone (ZDd) for the treatment of pts with MM who received ≥1L of prior therapy incl. a proteasome inhibitor & an immunomodulatory agent Approval was supported by the P-III (EXCALIBER-RRMM) trial assessing ZDd (n=207) vs daratumumab + bortezomib + dexamethasone (DVd;…
August 14, 2026

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NEWS

Taiho Oncology, Taiho Pharmaceutical and Cullinan Report P-III (REZILIENT3) Trial Data on Zipalertinib for 1L EGFRm NSCLC

Shots: The companies have reported the global P-III (REZILIENT3) trial assessing zipalertinib + Pt-based CT vs CT alone in the 1L treatment of 285 adults with previously untreated, locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations Trial met its 1EP of PFS, showing improvement with the zipalertinib-containing regimen at interim analysis, with the IDMC recommending unblinding the…
August 13, 2026

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NEWS

Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

Shots: The US FDA has granted 510(k) clearance to Saber-XA, an anterior lumbar interbody fusion (ALIF) system combining an expandable cage with a zero-profile anterior lumbar plate, enabling intra-operative customization of implant height & lordosis Saber-XA allows surgeons to independently adjust implant height & lordotic angle based on patient anatomy, with multiple configurations across its…
August 12, 2026

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