Breast Cancer
Dec 26, 2025
ENHERTU Plus Pertuzumab Approved in Breast Cancer: First New First-Line Option in Over a Decade
The pharmaceutical landscape for HER2-positive metastatic breast cancer has undergone a significant transformation with the FDA's approval of ENHERTU (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab as a first-line treatment—marking the first new therapeutic option approved in more than a decade for...
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Dec 16, 2025
Pilatus Biosciences Advances PLT012 Into the Clinic Following FDA IND Clearance; ENHERTU + pertuzumab Receives US Approval as the First New First-line Option in a Decade for HER2-positive Metastatic Breast Cancer; Sanofi Reports on Tolebrutinib Development in Primary Progressive MS; Gilead Reports Positive Phase 3 Results for Bictegravir–Lenacapavir Investigational HIV Therapy; argenx Announces Study Update for UplighTED Program of Efgartigimod SC in Thyroid Eye Disease
Pilatus Biosciences Receives FDA IND Clearance for PLT012, a Novel Anti-CD36 Metabolic Checkpoint Antibody Pilatus Biosciences has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PLT012, a first-in-class, humanized anti-CD36 monoclonal ant...
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Oct 17, 2025
Seagen’s TUKYSA Powers Pfizer’s Next HER2-Positive Breast Cancer Milestone
Pfizer’s oncology pipeline has achieved a second positive phase III trial in HER2-positive breast cancer within roughly a year. This latest success involves TUKYSA, a HER2-targeted tyrosine kinase inhibitor that Pfizer acquired through its $43 billion purchase of Seagen. In patients with HER2-positive metastatic...
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Sep 30, 2025
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year; Eli Lilly’s INLURIYO Approved for ER+, HER2-, ESR1-Mutated Advanced Breast Cancer; Janssen’s TREMFYA Secures FDA Nod for Pediatric Plaque Psoriasis and Psoriatic Arthritis; Kedrion Biopharma’s QIVIGY Approved for Primary Humoral Immunodeficiency in Adults; Crinetics Pharma Wins FDA Approval for First Daily Pill, PALSONIFY, for Rare Growth Disorder
Regeneron’s EVKEEZA Wins FDA Approval for HoFH in Children as Young as 1 Year Regeneron Pharmaceuticals, Inc. announced that the FDA has approved EVKEEZA (evinacumab-dgnb) ANGPTL3 antibody, for children aged 1 to under 5 years with homozygous familial hypercholesterolemia (HoFH). This expands the indication from...
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Aug 20, 2025
ENHERTU’s Rapid Rise: How the HER2-Targeting ADC Is Redefining Cancer Treatment with Back-to-Back Label Expansions
ENHERTU, a next-generation antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo/ AstraZeneca since March 2019, except in Japan, where Daiichi Sankyo maintains exclusive rights. It is worth noting that recently, in November 2024, Daiichi Sankyo and AstraZeneca were awarded the Galien Foundation 2024 Pri...
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Aug 05, 2025
Anbogen’s ABT-301 Cleared by FDA for Phase I/II Colorectal Cancer Trial; Dyne’s DYNE-251 Gets FDA Breakthrough Tag for Duchenne Muscular Dystrophy; BMS’s BREYANZI Accepted for FDA Priority Review in MZL; Clarametyx’s CMTX-101 Earns FDA Fast Track and QIDP for Infections; Anixa Begins FDA-Approved IND Transfer for Phase II Breast Cancer Vaccine Trial
Anbogen Secures FDA Nod to Begin Phase I/II Trial of ABT-301 Triplet in Advanced Colorectal Cancer Anbogen Therapeutics has received FDA clearance to initiate a Phase I/II clinical trial of ABT-301 in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC). The study w...
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Mar 27, 2025
Alcon Gains CE Mark for Clareon Vivity IOL in Europe; MicroPort MedBot’s Toumai SP Robot Wins NMPA Approval; Abbott Launches Intravascular Lithotripsy Trial; BD Advances GalaFLEX LITE™ Clinical Trial; GE HealthCare Unveils AI-Powered Invenia ABUS Premium; Okami Medical Introduces SENDERO® MAX Catheter
Alcon Announced CE Mark Approval and Launch of Clareon Vivity IOL in Europe, Expanding Visual Options On March 25, 2025, Alcon, the global leader in eye care committed to enhancing vision, announced that Vivity®, the most widely implanted extended depth of focus (EDOF) intraocular lens (IOL), became availa...
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Dec 09, 2024
How CDK4/6 Inhibitors Are Changing the Cancer Treatment Paradigm?
In the rapidly evolving landscape of cancer therapy, one class of drugs is making waves for its game-changing impact: CDK4/6 inhibitors. These revolutionary agents are rewriting the narrative for treating cancers driven by uncontrolled cell division, particularly hormone receptor-positive, HER2-negative breast canc...
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Nov 04, 2024
CDK7 Inhibitors: A Promising Class in Cancer Therapeutics
Cyclin-dependent kinase 7 (CDK7) belongs to the CDK family of serine/threonine protein kinases and plays a crucial role in regulating the cell cycle and mRNA transcription. It is often overexpressed in various cancers, making it a promising target for cancer treatment due to its involvement in both transcription an...
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Aug 14, 2024
Breast Cancer Insights: Identifying Symptoms and Protecting Your Health
Breast cancer is the most common form of cancer in women. Each year, it affects over 2 million women globally and is the most significant cause of death among women. Among the many types of breast cancer, a particularly formidable foe is Triple-negative breast cancer (TNBC), which accounts for 10-20% of all cases. ...
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