Breast Cancer
Jun 08, 2026
Oral SERDs Defy the Odds Amid a History of Pipeline Setbacks
Summary HR+/HER2- breast cancer continues to represent a major target indication for SERDs, with approximately 481,000 cases reported in 2024 in the 7MM. High-profile failures from Sanofi (amcenestrant) and a long list of early-stage candidates such as GDC-029, AZD9496, GDC-0927, ZnC5, LSZ-102, brinale...
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May 19, 2026
BAXFENDY Receives US Approval for Adult Hypertension as a First-in-Class Aldosterone Synthase Inhibitor; Regeneron Pharmaceuticals Shares New Developments in Phase 3 Melanoma Study of Fianlimab Combination; ENHERTU Gains Two New US Indications in HER2-positive Early Breast Cancer; REGENXBIO Reveals Positive Pivotal Trial Results for Duchenne Gene Therapy RGX-202; BeOne Medicines Gains FDA Approval for BEQALZI™ in R/R Mantle Cell Lymphoma
BAXFENDY Becomes the First FDA-Approved Aldosterone Synthase Inhibitor for Adults With Hypertension AstraZeneca’s BAXFENDY (baxdrostat) has received US approval as the first aldosterone synthase inhibitor (ASI) for treating hypertension in adults whose blood pressure remains uncontrolled despite the use of other...
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Mar 24, 2026
Sanofi’s Venglustat Gains US Breakthrough Therapy Nod, Boosting Hope for Type 3 Gaucher Disease; Rhythm Pharmaceuticals Expands IMCIVREE Label with FDA Approval in Hypothalamic Obesity; FDA Approves LYNAVOY for Cholestatic Pruritus in PBC Patients; FDA Greenlights J&J/Protagonist’s ICOTYDE, Redefining First-Line Systemic Therapy for Plaque Psoriasis; Novartis Strengthens its Breast Cancer Portfolio Through Acquisition of a Pan-mutant PI3Kα Inhibitor
Sanofi Wins US Breakthrough Therapy Tag for Venglustat in Type 3 Gaucher Disease The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to venglustat, an investigational oral glucosylceramide synthase inhibitor (GCSi), for treating neurological symptoms associated with type 3 Gauc...
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Mar 10, 2026
Roche Reveals Update from Phase III persevERA Study Targeting ER-Positive Advanced Breast Cancer; Ipsen Confirms Voluntary Withdrawal of TAZVERIK for Select Oncology Indications; Bristol Myers Squibb Unveils Positive Phase 3 Data from SUCCESSOR-2 Study Evaluating Mezigdomide in R/R Multiple Myeloma; Servier Announces Acquisition of Day One Biopharmaceuticals to Bolster Rare Cancer Portfolio; Pfizer Advances Trispecific Antibody with Positive Phase 2 Results in Atopic Dermatitis
Roche Announces Latest Findings from Phase III persevERA Study in ER-Positive Advanced Breast Cancer Roche announced results from the Phase III persevERA Breast Cancer study evaluating the investigational oral selective estrogen receptor degrader (SERD) giredestrant in combination with the CDK4/6 inhibitor palbo...
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Dec 30, 2025
Novo Nordisk Gains US Approval for Oral WEGOVY; Windward Bio Strengthens Immunology Pipeline With Clinical-Stage Bispecific WIN027; US FDA Grants Breakthrough Therapy Designation to ENHERTU in the Post-neoadjuvant Setting for HER2-positive Early Breast Cancer; Ipsen Enhances Early R&D Pipeline via Simcere Zaiming ADC; Roche Secures FDA Approval for SC Lunsumio VELO in Follicular Lymphoma
Novo Nordisk Secures US Approval for WEGOVY Novo Nordisk has achieved a significant regulatory milestone with the U.S. FDA approval of WEGOVY (semaglutide) for the treatment of obesity in pediatric patients aged 12 years and older. While WEGOVY has already revolutionized the adult weight management market, this ...
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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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