Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

Shots: FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET) Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the…

ByRidhi RastogiSeptember 21, 2026

EMA Marketing Authorization of New Drugs in January 2026

Shots: The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka. The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock. Decisions were backed by strong Phase II/III data…

ByDipanshu DixitFebruary 17, 2026

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

Shots: FDA approved Inluriyo (200mg; PO) for treating adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy; US availability expected in the coming wks. Approval was based on P-III (EMBER-3) trial (N=874: 32% in 1L & 64% in 2L treatment post progression) assessing Inluriyo ± abemaciclib vs fulvestrant/exemestane…

ByRidhi RastogiSeptember 26, 2025

Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

EMA Marketing Authorization of New Drugs in January 2026

Eli Lilly’s Inluriyo (Imlunestrant) Receives the US FDA’s Approval for ESR1-mutated Breast Cancer

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