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Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…
June 15, 2026

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Astrazeneca
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AstraZeneca’s Truqap Combination Receives the US FDA Approval for PTEN-Deficient mAPMN/S Prostate Cancer

Shots: FDA has approved AZ's Truqap + abiraterone & ADT, along with its companion diagnostic test for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer; regulatory review is ongoing in the EU Approval was based on the global P-III (CAPItello-281) trial assessing Truqap + abiraterone & ADT vs PBO + abiraterone…
June 15, 2026

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NEWS

Oncolys BioPharma Reports MHLW Approval of Telomelysin for Esophageal Cancer

Shots: The Japanese MHLW has granted full marketing approval to Telomelysin Injection (suratadenoturev/OBP-301) for the treatment of esophageal cancer pts ineligible for curative resection or CT, based on a Japanese pivotal trial conducted at 17 sites Approval triggered a milestone payment to Oncolys under its deal with FUJIFILM Toyama Chemical, which granted FUJIFILM commercialization rights…
June 10, 2026

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Eli lilly
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Eli Lilly Receives the US FDA Approval for Ebglyss as a Q8W Maintenance Therapy for Atopic Dermatitis

Shots: The US FDA has approved Ebglyss (lebrikizumab-lbkz; 250mg/2mL, Q8W, SC) maintenance therapy for the treatment of pts (≥12yrs.; ≥40kg) with mod. to sev. atopic dermatitis Approval was supported by longitudinal exposure-response modeling & Q8W dosing data from an extension of the P-III (Adjoin) long-term trial, which assessed Ebglyss maintenance dosing for Q4W or Q8W over…
June 10, 2026

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NEWS

Chiesi Reports the EC Approval of Lojuxta to Treat Homozygous Familial Hypercholesterolaemia in Pediatric Patients

Shots: The EC has approved Lojuxta (lomitapide capsules) for the treatment of children (≥5yrs.) with Homozygous Familial Hypercholesterolaemia (HoFH), alongside diet & other lipid-lowering treatments, incl. LDL-apheresis Approval was based on the P-III (APH-19) trial evaluating Lojuxta in 43 pediatric pts (5 to 17yrs.) with HoFH Trial met its 1EP, showing a mean 53.5% reduction…
June 5, 2026

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NeuroPace Receives the US FDA Approval for ECoG Assistant to Advance AI-Driven Epilepsy Care

Shots: The US FDA has approved ECoG Assistant, an AI-powered clinician tool designed to support epilepsy management using data from the RNS System, with NeuroPace debuting the tool at ASSFN’26 ECoG Assistant was developed using 124,450 epileptologist-labeled intracranial EEG records & identifies ECoGs of Interest, enabling clinicians to review long-term EEG trends & circadian activity…
June 1, 2026

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