EMA Decision

Venetoclax-Dexamethasone Trial for t(11;14) Relapsed/Refractory Amyloidosis Initiated

A clinical trial is underway to evaluate the safety and efficacy of venetoclax combined with dexamethasone for relapsed or refractory t(11;14) light chain amyloidosis.

Systematic review on EGFR alterations in recurrent glioblastoma therapy response

The review assesses the predictive value of EGFR amplification and EGFRvIII mutation for EGFR-targeted therapy in recurrent glioblastoma.

Study on Hemato-immunological Parameters in Immune Thrombocytopenic Purpura

A study is underway to identify hemato-immunological parameters that predict the chronicity of Immune Thrombocytopenic Purpura (ITP) and differences between pediatric and adult populations.

Guidance on Distinction Between Angioedema Types for ACE-Inhibitor Users

Healthcare professionals are advised about the delayed onset of angioedema and the differing treatment strategies for bradykinin- versus histamine-mediated cases.

Advancements in NK Cell-Based Immunotherapy for Cancer Treatment

NK cell therapies are advancing with promising safety profiles and clinical applicability, leveraging various innovative strategies.

Lilly to present positive Phase 3 results for pirtobrutinib in CLL at EHA 2026

Apotex Inc. Submits ANDA for Ruxolitinib

Apotex Inc. has submitted an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating a move to enter the market.

FDA Proposes Exclusion of Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List

The FDA has proposed to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, indicating no clinical need for compounding these drugs.

FDA Lists Quinacrine Hydrochloride for Compounding in Cutaneous Lupus Erythematosus

Quinacrine is included on the FDA 503B list for compounding, indicating a clinical need for its use in treating cutaneous lupus erythematosus.

SillaJen initiates Phase 1 trial of BAL0891 in advanced solid tumors and AML

SillaJen is conducting Phase 1 trial of BAL0891, evaluating its safety and tolerability in advanced solid tumors and relapsed/refractory AML.

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

A study is underway to evaluate nemtabrutinib against ibrutinib or acalabrutinib in treatment-naive CLL/SLL patients.

FDA Draft Guidance Aims to Reduce Animal Testing for Cancer Drugs

The FDA has issued draft guidance to minimize unnecessary animal testing in the development of cancer drugs.

Phase III Trial of Hemay005 in Chinese Patients with Ulcerative Colitis Initiated

A phase III trial has been initiated to evaluate Hemay005 for the treatment of moderately to severely active ulcerative colitis in Chinese patients.

FDA Accepts Roche's Gazyva for Systemic Lupus Erythematosus Treatment

The FDA has accepted Roche's sBLA for Gazyva/Gazyvaro, based on phase III ALLEGORY data showing significant efficacy in SLE.

Roche Reports Strong Q1 2026 Sales Growth Driven by Innovative Medicines and Diagnostics

Roche's Q1 2026 sales grew 6% at constant exchange rates, driven by strong demand for innovative medicines, particularly in multiple sclerosis and oncology.

CVS Caremark to cover Foundayo and Zepbound, enhancing access for obesity treatment

CVS Caremark will cover Foundayo starting June 1 and Zepbound from October 1, allowing eligible patients to pay as low as $25 monthly.

Saphnelo Self-Administration Approved in the US for SLE Treatment

AstraZeneca's Saphnelo has received FDA approval for self-administration via a new autoinjector, enhancing patient convenience.

European Commission Approves Pfizer’s HYMPAVZI for Hemophilia A and B Treatment

The European Commission has approved HYMPAVZI for treating hemophilia A or B in patients 12 years and older with inhibitors, based on Phase 3 data showing significant bleed reduction.

Lilly's Foundayo shows superior A1C reduction and weight loss in pivotal diabetes trials

Foundayo (orforglipron) demonstrated a 57.1% greater reduction in A1C and significant weight loss compared to oral semaglutide in pivotal trials.

Lilly's Foundayo shows superior results in Phase 3 trial for type 2 diabetes

Phase 3 ACHIEVE results indicate Foundayo outperformed oral semaglutide and dapagliflozin in treating type 2 diabetes.

Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion for Muscle-Invasive Bladder Cancer

The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.

Roche and Nurix Collaborate on BTK Degrader Bexobrutideg for B-cell Malignancies

Roche has entered a collaboration with Nurix Therapeutics to co-develop bexobrutideg, a novel BTK degrader targeting B-cell malignancies, immunology, and neurology.

Pfizer's LORBRENA CROWN Trial Reports Longest Progression-Free Survival in Advanced NSCLC

The seven-year analysis of the CROWN trial shows a 55% likelihood of remaining alive without disease progression for patients treated with LORBRENA, with median progression-free survival not reached.

Lilly's Jaypirca shows 45% reduction in disease progression risk in CLL/SLL

Jaypirca (pirtobrutinib) significantly reduced the risk of disease progression or death by 45% when added to a venetoclax regimen in previously treated CLL/SLL patients.

Lilly presents promising Phase 1 data for first-in-class type II JAK2 inhibitor in myelofibrosis

Lilly's AJ1-11095, a type II JAK2 inhibitor, shows an encouraging safety profile and promising clinical activity in myelofibrosis patients.

FDA Approves Pfizer’s HYMPAVZI for Expanded Hemophilia A and B Indications

The FDA has approved an expanded indication for Pfizer’s HYMPAVZI to treat hemophilia A or B in patients aged 6 and older, including those with inhibitors.

Enhertu recommended for EU approval in HER2+ metastatic solid tumours

Enhertu has been recommended for approval by the CHMP for patients with previously treated HER2-positive metastatic solid tumours.

Zhuochuming® Trial Evaluates 3+T&E vs 3+PRN in Diabetic Macular Edema

A clinical trial is underway to compare the efficacy of Zhuochuming® using a 3+T&E regimen against a 3+PRN regimen in treating treatment-naïve patients with diabetic macular edema.