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Eli lilly
NEWS

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

Incyte to Acquire Vega Therapeutics for ~$2B

Shots: Incyte has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics, to expand its hematology portfolio into bleeding disorders As per the deal, Incyte will acquire Vega for $1.25B upfront, with ~$750M in additional payments upon achievement of sales milestones Acquisition will expand Incyte’s hematology portfolio with…
June 8, 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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NEWS

Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…
June 5, 2026

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Innovent
NEWS

Innovent Reports the P-III Trial Results on Arcotatug Tavatecan in G/GEJ Adenocarcinoma 

Shots: Innovent has reported the P-III (G-HOPE-001) of arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2 positive, locally advanced unresectable or metastatic G/GEJA who have received ≥2 prior therapies Trial met its 1EP of improved PFS in the interim analysis & showed a favorable safety profile; data to be published in future…
June 4, 2026

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Celcuity
NEWS

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…
June 3, 2026

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Astrazeneca
NEWS

AstraZeneca Highlights P-III (SERENA-6) Trial Data on Camizestrant Combination for ESR1 Mutated Advanced Breast Cancer at ASCO’26

Shots: AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…
June 3, 2026

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Gilead
NEWS

Gilead Reports the P-III (IDEAL) Trial Data on Livdelzi (Seladelpar) in Primary Biliary Cholangitis (PBC)

Shots: Gilead has reported the P-III (IDEAL) trial data assessing Livdelzi (seladelpar) vs PBO in 96 adults (18-75yrs.) with PBC who have inadequately controlled disease, on or intolerant to ursodeoxycholic acid Trial showed that a higher proportion of pts treated with Livdelzi achieved normalization of ALP after 52wks.; data to be presented at a future conference & discussed…
June 3, 2026

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NEWS

Genentech Receives the US FDA Priority Review for Giredestrant as an Adjuvant Treatment of ER+ Early-Stage Breast Cancer

Shots: The US FDA has accepted NDA & granted priority review to Genentech’s giredestrant as an adj. treatment for adults with ER+, HER2-, ESR1-mutated stage I, II, and III breast cancer (PDUFA: Nov 30, 2026) NDA was supported by the P-III (lidERA Breast Cancer) trial (n>4,100), where adj. giredestrant reduced iDFS by 30%, with 92.4%…
June 2, 2026

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