Roche

Trial Evaluates Faricimab vs Fluocinolone for Radiation Retinopathy Prevention

A randomized controlled trial is assessing the efficacy of intravitreal faricimab and fluocinolone acetonide implants against observation for preventing vision loss due to radiation retinopathy.

Genentech's ITOVEBI NDA219249 Submission Receives AP Status

The FDA has granted an Approval Pending (AP) status for Genentech's supplemental NDA for ITOVEBI (Inavolisib).

Phase 2 Study of Mosunetuzumab in CLL Patients Post-BTKi Treatment

A Phase 2 study is underway to evaluate the efficacy of mosunetuzumab in CLL patients with detectable disease after BTKi treatment.

CHMP recommends EU approval of Roche’s Susvimo for neovascular AMD

The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for neovascular AMD, based on positive clinical trial data.

CHMP recommends EU approval of Roche’s Susvimo for nAMD treatment

The CHMP has recommended the approval of Susvimo, a continuous delivery treatment for nAMD, based on clinical trial data.

Genentech's OpRegen Study Targets Geographic Atrophy in AMD with Subretinal Delivery

Genentech is conducting a study to evaluate the safety and activity of OpRegen delivered via subretinal surgery in patients with geographic atrophy secondary to AMD.

Roche Reports Strong H1 2026 Sales Growth and Multiple FDA Priority Reviews

Roche's pharmaceuticals division saw a 6% sales increase in H1 2026, driven by key products and multiple FDA Priority Reviews for new therapies.

Roche Reports Strong H1 2026 Sales and Multiple FDA Priority Reviews

Roche's H1 2026 sales increased by 6% at constant exchange rates, driven by strong demand for innovative medicines. The FDA granted Priority Reviews for five key therapies, including giredestrant for breast cancer and Enspryng for thyroid eye disease.

Roche Reports Strong H1 2026 Sales Growth and Multiple FDA Priority Reviews

Roche received five FDA Priority Reviews for key therapies including giredestrant for early-stage breast cancer and Enspryng for thyroid eye disease.

Phase I/II Study of GDC-7035 in Advanced Solid Tumors with KRAS G12D Mutation

Genentech is conducting a first-in-human Phase I/II study of GDC-7035 targeting KRAS G12D mutations in advanced solid tumors.

FDA Accepts Supplement Application for COLUMVI (GLOFITAMAB-GXBM)

The FDA has accepted the supplemental application for COLUMVI, a bispecific T-cell engager.

Phase I Study of RO7566802 in Combination with Atezolizumab for Solid Tumors

Genentech is conducting a first-in-human Phase I trial to evaluate RO7566802 alone and with atezolizumab in advanced solid tumors.

Hoffmann-La Roche's Prasinezumab Trial Targets Early-Stage Parkinson's Disease

A clinical trial is underway to assess the efficacy and safety of intravenous prasinezumab in early-stage Parkinson's disease patients.

Phase Ib/II Study of Glofitamab with Atezolizumab or Polatuzumab in B-Cell NHL

A Phase Ib/II study is assessing the safety and efficacy of Glofitamab combined with Atezolizumab or Polatuzumab in relapsed/refractory B-cell NHL.

Hoffmann-La Roche Evaluates Petrelintide and Enicepatide in Obesity Trial

A dose-finding study is underway to assess the safety and efficacy of petrelintide combined with enicepatide in adults with obesity.

FDA Approves HERCEPTIN HYLECTA Supplement Application

The FDA has approved the supplemental application for HERCEPTIN HYLECTA, which combines trastuzumab and hyaluronidase.

FDA Approves PHESGO Supplement for Genentech's Combination Therapy

The FDA has approved a supplemental application for PHESGO, a combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf.

FDA Grants Priority Review for Tecentriq Hybreza Supplement Application

The FDA has granted priority review for the supplemental application of Tecentriq Hybreza, which combines atezolizumab with hyaluronidase.

FDA Grants Priority Review for Tecentriq Supplement Application

The FDA has granted priority review for the supplemental application of Tecentriq (atezolizumab) submitted by Genentech.

Roche's Elecsys IGRA TB Test Receives CE Mark for Tuberculosis Detection

Roche's Elecsys IGRA TB test has received CE Mark approval, enabling rapid and efficient tuberculosis infection testing.

FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for primary membranous nephropathy

The FDA has granted Priority Review for Gazyva/Gazyvaro based on phase III MAJESTY results showing significant remission rates in primary membranous nephropathy.

FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for primary membranous nephropathy

The FDA has granted Priority Review for Gazyva/Gazyvaro based on phase III MAJESTY results showing superior remission rates in primary membranous nephropathy.

Divarasib Study in Untreated Advanced NSCLC Shows Promise for Safety and Efficacy

A study is underway to evaluate the safety, pharmacokinetics, and activity of divarasib in advanced or metastatic NSCLC.

FDA Grants Priority Review for OCREVUS Supplemental Application

The FDA has granted priority review for the supplemental application of OCREVUS (ocrelizumab) submitted by Genentech.

Roche launches first fully automated cobas HDV test for Hepatitis D diagnosis

Roche has introduced the cobas HDV test, the first fully automated diagnostic solution for Hepatitis D Virus.

Roche Launches First Fully Automated HDV Test to Enhance Diagnosis and Monitoring

Roche has introduced the cobas HDV test, the first fully automated diagnostic solution for Hepatitis D Virus, enhancing diagnosis and treatment monitoring.

Genentech's GDC-1261 Study Targets Advanced Prostate Cancer Safety and Activity

Genentech is conducting a study to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-1261 in advanced or metastatic prostate cancer.

Divarasib Study Targets KRAS G12C-Positive NSCLC Post-Chemoimmunotherapy

A study is underway to evaluate divarasib's efficacy against standard immunotherapy options in NSCLC patients.

Roche's Elecsys IGRA TB Test Receives CE Mark for Tuberculosis Detection

Roche's Elecsys IGRA TB test has received CE Mark approval, enabling rapid and automated tuberculosis infection testing.

Hoffmann-La Roche initiates trial for trontinemab in early symptomatic Alzheimer's disease

A clinical trial is underway to evaluate the efficacy and safety of trontinemab in early symptomatic Alzheimer's disease.

FDA Accepts Supplement for COLUMVI (GLOFITAMAB-GXBM) by Genentech

The FDA has accepted a supplemental biologics license application for COLUMVI, a bispecific T-cell engager.

Phase III Trial of Afimkibart Shows Promise for Moderately to Severely Active Crohn's Disease

A Phase III trial is underway to assess the efficacy and safety of Afimkibart in Crohn's disease patients.

Roche to present new Alzheimer’s data, including trontinemab and pTau217 blood test, at AAIC 2026

Roche will present new long-term data on trontinemab and the Elecsys pTau217 blood test at AAIC 2026, highlighting advancements in Alzheimer's diagnostics and treatment.

Roche presents new Alzheimer’s data at AAIC 2026, highlighting trontinemab and blood tests

Roche will present new long-term data on trontinemab and the Elecsys pTau217 blood test at AAIC 2026.

FDA Accepts Supplemental Application for PERJETA by Genentech

The FDA has accepted a supplemental application for PERJETA (pertuzumab) from Genentech.

Genentech's Belvarafenib Trial in NRAS-mutant Advanced Melanoma Initiated

A study is underway to evaluate belvarafenib's safety and activity as a monotherapy and in combination with cobimetinib and nivolumab in NRAS-mutant advanced melanoma patients.

FDA Accepts Supplement for Inavolisib by Genentech

The FDA has accepted a supplemental NDA for Inavolisib submitted by Genentech.

Genentech initiates study on cevostamab and elranatamab for relapsed/refractory multiple myeloma

Genentech is evaluating the safety and pharmacokinetics of cevostamab in combination with elranatamab for R/R MM.

Phase II Study of HER2 Imaging as Biomarker for T-DM1 in Advanced Breast Cancer

The ZEPHIR-02 trial will evaluate 89Zr-trastuzumab PET/CT as a predictive biomarker for T-DM1 treatment in HER2-positive mBC patients post T-DXd progression.

Phase III Trial of Afimkibart Shows Promise for Ulcerative Colitis

A Phase III trial is underway to assess the efficacy and safety of Afimkibart in patients with moderately to severely active ulcerative colitis.

Genentech's Vixarelimab Shows Promise in Moderate to Severe Ulcerative Colitis

A study is underway to evaluate the pharmacodynamic effects of vixarelimab in patients with moderate to severe active ulcerative colitis.

Roche's Divarasib Shows Best-in-Class Potential in Phase III NSCLC Trial

The Phase III Krascendo 1 trial demonstrated that divarasib significantly improves progression-free and overall survival compared to existing KRAS G12C inhibitors.

Roche's Divarasib Shows Best-in-Class Potential in Phase III NSCLC Trial

FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease

The FDA has granted priority review for Roche's Enspryng (satralizumab) as a treatment for thyroid eye disease, based on positive phase III trial results.

FDA Grants Priority Review for Roche's Enspryng in Thyroid Eye Disease

The FDA has granted priority review for Roche's Enspryng (satralizumab) for treating thyroid eye disease, based on positive phase III trial results.

Roche Launches AXELIOS 1 Next-Generation Sequencing Platform

Roche has launched the AXELIOS 1 platform, a next-generation sequencing solution that offers high accuracy, speed, and cost efficiency.

Roche Launches AXELIOS 1 Next-Generation Sequencing Platform

Roche has launched AXELIOS 1, a next-generation sequencing platform utilizing innovative SBX technology for rapid and accurate whole-genome sequencing.

FDA Accepts Supplement Application for LUNSUMIO (Mosunetuzumab-axgb)

The FDA has accepted a supplemental application for LUNSUMIO, a bispecific T-cell engager.

FDA Accepts Supplemental BLA for OCREVUS ZUNOVO by Genentech

The FDA has accepted the supplemental BLA for OCREVUS ZUNOVO, which includes ocrelizumab and hyaluronidase.

Entrectinib Phase 1/2 Study in Pediatric Solid Tumors and CNS Tumors Initiated

A Phase 1/2 study of Entrectinib in pediatric patients with advanced solid tumors and CNS tumors has been initiated.

Hoffmann-La Roche's Enicepatide Trial Targets Obesity and Type 2 Diabetes

A clinical study is underway to evaluate enicepatide's efficacy and safety in managing weight for obese or overweight participants with Type 2 diabetes.

Hoffmann-La Roche initiates study on RO7663498 for diabetic retinopathy

A new study is underway to evaluate the safety, tolerability, and pharmacokinetics of RO7663498 in diabetic retinopathy patients.

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.

FDA Accepts Supplemental Application for ALECENSA (Alectinib Hydrochloride)

The FDA has accepted a supplemental application for ALECENSA, indicating ongoing development and potential label expansion.

Risdiplam Study to Assess Real-World Outcomes in Type I and II SMA

A multicenter study will evaluate the real-world clinical outcomes and safety of Risdiplam in SMA patients over 24 months.

RAPTOR Trial Evaluates Radiation Therapy with Atezolizumab in Extensive Stage Small Cell Lung Cancer

The RAPTOR trial is assessing the efficacy of adding radiation therapy to atezolizumab maintenance in extensive stage small cell lung cancer.

FDA Accepts Supplement Application for ENSPRYNG (Satralizumab)

The FDA has accepted the supplemental application for ENSPRYNG (satralizumab) submitted by Genentech.

Genentech initiates study on progression of intermediate age-related macular degeneration

Genentech is conducting a multicenter observational study to assess disease progression in intermediate age-related macular degeneration over approximately 3 years.

Phase III Trial of Atezolizumab with Chemotherapy for Metastatic Colorectal Cancer Initiated

The COMMIT study is evaluating the efficacy of atezolizumab in combination with chemotherapy and bevacizumab for metastatic colorectal cancer with DNA mismatch repair deficiency.

Study on Educational Intervention for Breast Cancer Patients' Adherence and Sexual Function

This study evaluates the impact of an educational intervention on sexual function and treatment adherence in women with breast cancer.

Study on Early Rehabilitation Protocol for Breast Cancer Surgery Shows Promising Safety and Feasibility

A new early rehabilitation protocol, EMOVE-BCS-LaFe, is being evaluated for safety and feasibility in breast cancer surgery patients.

STARD10's Role in HER2+ Breast Cancer Progression and Lipid Metabolism

STARD10 is implicated in the progression of HER2+ breast cancer and regulates intracellular lipid metabolism via the cAMP/PKA/CREB1 signaling pathway.

Large Study on Breast Phyllodes Tumors in China Aims to Enhance Treatment Guidelines

A multi-center, retrospective study will analyze real-world data from 3,500 patients with breast phyllodes tumors in China.

Phase III Trial Compares 6 vs. 12 Months of HER2-Targeted Therapy in Breast Cancer

A phase III trial is investigating whether 6 months of HER2-targeted therapy is more effective than 12 months for HER2-positive breast cancer patients who achieved a pathologic complete response after neoadjuvant chemotherapy.

Phase III Trial of Herceptin Hylecta or Phesgo with Chemotherapy for HER2 Positive Endometrial Cancer

A phase III trial is testing the efficacy of adding Herceptin Hylecta or Phesgo to standard chemotherapy in HER2 positive endometrial cancer.

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's ENSPRYNG shows 68% relapse reduction in Phase III MOGAD study

The Phase III METEOROID study demonstrated that ENSPRYNG (satralizumab) reduced the risk of relapses by 68% in MOGAD patients.

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.

Phase II Trial Compares FOLFOX8 and mFOLFOX6 in Metastatic Colorectal Cancer

A phase II trial is underway to compare the efficacy and safety of FOLFOX8 versus mFOLFOX6 with bevacizumab or cetuximab in patients with unresectable metastatic colorectal cancer.

Overview of Antibody-Drug Conjugates in Cancer Therapy and Clinical Development

Antibody-drug conjugates (ADCs) have shown significant clinical benefits in advanced phase trials for various cancers, with over a dozen receiving FDA approval.

Roche Presents New Data on Vabysmo and Susvimo at ARVO 2026

New real-world data confirm Vabysmo's effectiveness in drying the retina for nAMD and DME, while Susvimo shows potential for sustained disease control.

Roche to Present Phase II Data on Enicepatide and Petrelintide at ADA 2026

Roche will present new Phase II data for enicepatide and petrelintide in obesity at the ADA Scientific Sessions.

Roche to Acquire PathAI for $750M to Enhance AI-Driven Diagnostics

Roche has entered into a definitive agreement to acquire PathAI for $750 million, enhancing its digital pathology capabilities.

Roche to Acquire PathAI for $750M to Enhance AI-Driven Diagnostics

Roche has entered into a definitive merger agreement to acquire PathAI for $750 million, enhancing its digital pathology capabilities.

Roche to Present Phase II Data on Enicepatide and Petrelintide at ADA 2026

Roche will present new data from the Phase II studies of enicepatide and petrelintide in obesity at the ADA Scientific Sessions.

Roche's Elecsys® pTau217 Blood Test Receives CE Mark for Alzheimer's Detection

Roche has received CE Mark approval for Elecsys® pTau217, the first blood test designed to detect Alzheimer's disease pathology.

Roche's Elecsys® pTau217 Blood Test Receives CE Mark for Alzheimer's Diagnosis

Roche has received CE Mark approval for Elecsys® pTau217, the first blood test for Alzheimer's disease pathology, enabling faster diagnosis.

Roche Launches Liver Disease Panel to Enhance Chronic Liver Disease Management

Roche has launched the Liver Disease Panel, a suite of certified algorithms aimed at improving the management of chronic liver disease (CLD). This panel includes the LiverPRO algorithm, which facilitates early detection of liver fibrosis using routine blood markers.

Roche Advances Obesity Portfolio with Promising Phase II Data on Enicepatide and Petrelintide

Roche presented late-breaking Phase II data showing significant efficacy and safety for enicepatide and petrelintide in weight management.

Roche Advances Obesity Portfolio with Promising Phase II Data for Enicepatide and Petrelintide

Roche presented late-breaking Phase II data showing significant efficacy and safety for enicepatide and petrelintide in weight management.

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

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

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.

Roche to Present Promising Giredestrant Data at ASCO 2026 for Early Breast Cancer

Roche will present new data from the lidERA and persevERA studies, indicating giredestrant's potential as a new standard of care in early and advanced ER-positive breast cancer.

Roche to Present Promising Giredestrant Data at ASCO 2026 for Early Breast Cancer

Roche will present new data from the lidERA and persevERA studies, highlighting giredestrant's potential as a new standard of care for ER-positive breast cancer.

FDA Accepts NDA for Roche's Giredestrant in Early-Stage ER-Positive Breast Cancer

The FDA has accepted Roche's NDA for giredestrant, an oral SERD, under priority review based on phase III data showing a 30% reduction in invasive disease recurrence or death compared to standard therapy.

FDA Accepts NDA for Roche's Giredestrant in Early-Stage ER-Positive Breast Cancer

The FDA has accepted Roche's NDA for giredestrant, showing a 30% reduction in invasive disease recurrence compared to standard therapy.

Roche's VENTANA PTEN Assay Receives FDA Approval for Prostate Cancer Companion Diagnostic

Roche's VENTANA PTEN (SP218) RxDx Assay is the first FDA-approved companion diagnostic for assessing PTEN protein loss in prostate cancer.

FDA Grants Priority Review for Roche’s Tecentriq in Stage III Colon Cancer

The FDA has accepted Roche's sBLA for Tecentriq plus chemotherapy in stage III dMMR/MSI-H colon cancer, with a decision expected by October 9, 2026.

FDA grants Priority Review for Roche’s Tecentriq in stage III colon cancer

The FDA has accepted Roche's sBLA for Tecentriq in combination with chemotherapy for stage III dMMR/MSI-H colon cancer, with a decision expected by October 9, 2026.