Roche’s Giredestrant Combination Shows Significant Benefit in Advanced ER-Positive Breast Cancer

Roche

Roche’s Phase III evERA study for the investigational drug giredestrant has delivered positive results, showing a significant improvement in progression-free survival for patients with advanced ER-positive breast cancer. The all-oral combination therapy, which was well-tolerated, offers a new, promising treatment option for individuals whose disease has progressed after previous treatments.

U.S. FDA Approves Merck’s Keytruda Qlex, a Faster-Administered Subcutaneous Version of Keytruda for Cancer Treatment

Merck MSD

The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda Qlex, a new subcutaneous formulation of its leading cancer immunotherapy drug. This game-changing approval introduces a fixed-dose combination of pembrolizumab and berahyaluronidase alfa-pmph, allowing the treatment to be administered as a simple injection in as little as one minute, a significant reduction from the previous 30-minute intravenous infusion. Approved for most of Keytruda’s existing solid tumor indications in adults, this new formulation was shown in clinical trials to have a comparable efficacy and safety profile to the IV version. The approval marks a major advancement in patient-centered care, offering a more convenient and less time-consuming option for thousands of cancer patients.

U.S. FDA Approves Johnson & Johnson’s TREMFYA® (guselkumab) Subcutaneous Induction for Adults with Ulcerative Colitis

JohnsonAndJohnson

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a new subcutaneous (at-home) induction option for TREMFYA® (guselkumab) for adults with moderately to severely active ulcerative colitis. This approval, based on the successful Phase 3 ASTRO trial, makes TREMFYA the first and only IL-23 inhibitor to offer a completely subcutaneous regimen for both induction and maintenance, providing a significant new convenience for patients managing their condition.

Lilly’s Mounjaro Shows Promising Results in Teens with Type 2 Diabetes

Eli Lilly and Company

Eli Lilly and Company announced positive topline results from its SURPASS-PEDS Phase 3 trial for Mounjaro (tirzepatide). The study, which evaluated the GIP/GLP-1 dual receptor agonist in children and adolescents with type 2 diabetes, demonstrated substantial and statistically significant improvements in blood sugar control and weight management, with a safety profile consistent with adult studies.

Novo Nordisk Unveils Promising Phase 3 Data for Cagrilintide, a Novel Amylin Analogue for Obesity, Advancing to New Clinical Program

novo nordisk

Novo Nordisk has unveiled compelling phase 3 data for its next-generation obesity drug, cagrilintide, at the EASD 2025 congress. The novel amylin analogue demonstrated a significant 11.8% average body weight reduction over 68 weeks, far surpassing the placebo group. These promising results have prompted the company to advance cagrilintide into a new dedicated clinical program, RENEW, set to begin later this year.

Amgen and Kyowa Kirin Announce Positive Top-Line Results from Rocatinlimab Phase 3 Study for Atopic Dermatitis

amgen

Amgen and Kyowa Kirin announced positive top-line results from the ASCEND Phase 3 long-term study for rocatinlimab, an investigational treatment for adults and adolescents with moderate to severe atopic dermatitis. The study demonstrated a continued therapeutic benefit and a consistent safety profile, showing sustained improvements in skin clearance and itch reduction at one year.

AstraZeneca’s Tagrisso Combination Therapy Sets New Survival Benchmark in Advanced Lung Cancer

AstraZeneca

hase III trial called FLAURA2 has demonstrated that the combination of AstraZeneca’s drug, Tagrisso, with chemotherapy has led to a median overall survival of nearly four years for patients with a specific type of advanced lung cancer. This marks the longest survival benefit ever recorded in a global trial for this condition, solidifying Tagrisso as a standard-of-care treatment and providing a new benchmark for patient outcomes.

Lilly’s Olomorasib Granted U.S. FDA Breakthrough Therapy Designation for Advanced Lung Cancer

Eli Lilly and Company

Eli Lilly announced its novel cancer drug, olomorasib, has been granted Breakthrough Therapy designation by the U.S. FDA. This significant milestone aims to expedite the development of the treatment for patients with advanced KRAS G12C-mutated non-small cell lung cancer, a historically difficult-to-treat condition.

Lilly’s Oral GLP-1 Orforglipron Achieves Success in Third Phase 3 Trial, Triggering Global Regulatory Submissions

Eli Lilly and Company

Eli Lilly announced results from the Phase 3 ATTAIN-2 trial, where its oral GLP-1 receptor agonist orforglipron provided substantial weight loss and improved A1C for adults living with obesity and type 2 diabetes demonstrating efficacy and safety consistent with injectable medicines, and moving toward regulatory approval.