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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

Pfizer and Valneva Report EMA’s MAA Validation for PF-07307405 Against Lyme Disease

Shots: The EMA has validated the MAA for PF-07307405, a 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application developed in collaboration between Pfizer & Valneva The application is supported by >70% efficacy in the P-III (VALOR) trial, which evaluated PF-07307405 in individuals aged ≥5 years.…
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

Pharming Group Launches Joenja in Japan for APDS

Shots: Pharming Group has launched Joenja in Japan for activated PI3K delta syndrome (APDS) patients aged 4 years and older following NHI reimbursement listing As per the agreement with Pharming, OrphanPacific serves as Joenja’s Marketing Authorization Holder in Japan &, alongside Pharming, manages the product’s supply & distribution Leniolisib is under regulatory review for pediatric…
August 13, 2026

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NEWS

Definium Therapeutics Reports P-III (Voyage) Study on DT120 ODT in Generalized Anxiety Disorder (GAD)

Shots: Definium has reported topline P-III (Voyage) trial results assessing DT120 (lysergide, Orally Disintegrating Tablet, 100µg; n=107) vs PBO (n=107) in 214 adults with GAD Voyage met its 1EP, with DT120 improving HAM-A scores at Wk. 12 (-11.6 vs -6.2). Efficacy emerged by Day 2 & was sustained through all post-baseline timepoints in Part A Key…
August 13, 2026

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NEWS

Freenome’s SimpleScreen Lung Cancer Screening Test Secures Breakthrough Device Designation

Shots: The US FDA has granted Breakthrough Device Designation to SimpleScreen Lung to detect early signals of lung cancer in a blood sample from a standard blood draw SimpleScreen Lung builds on its base-level methylation & next-generation sequencing platform, combining methylation & proteomics with an AI/ML-powered classifier to detect lung cancer signals Freenome presented initial…
August 13, 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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