Articles by Dr. Emily Carter
Celcuity's Gedatolisib Meets Phase 3 Primary Endpoint in PIK3CA Mutant Cancer Trial
Celcuity's VIKTORIA-1 Phase 3 trial shows clinically meaningful progression-free survival improvement with gedatolisib in PIK3CA mutant patients.
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Enters Diabetes Market
FDA approves LANGLARA as interchangeable biosimilar to Lantus insulin glargine, marking Lannett Company's entry into diabetes treatment market through Lanexa Biologics.
FDA Approves Auvelity for MDD: Axsome Therapeutics Scores Win
The U.S. Food and Drug Administration (FDA) has approved Auvelity, a novel oral antidepressant developed by Axsome Therapeutics, for the treatment of Major Depressive Disorder (MDD) in adults. This approval represents a significant advancement in the mental health landscape.
Mirum Pharmaceuticals VISTAS Study Results for Volixibat in Primary Sclerosing Cholangitis Due May 4, 2026
Mirum Pharmaceuticals will announce topline results from the VISTAS study of volixibat for primary sclerosing cholangitis treatment on May 4, 2026.
BioMarin VOXZOGO Shows Long-Term Benefits for Achondroplasia in New Clinical Data at PES 2026
BioMarin presents new VOXZOGO data showing long-term benefits on arm span, bone health and growth in children with achondroplasia at PES 2026 meeting.
Biosimilar Uptake EU: Market Impact Post-Patent Expirations & HTA Regulation
This article examines how biosimilar adoption in the EU is reshaping the market landscape for biologics like Adalimumab after patent expirations and under HTA regulations.
PMDA Guideline Updates: Impact on Adaptive Trial Designs & Data Transparency
This article delves into the recent PMDA guideline updates and their implications for adaptive trial designs and data transparency in drug development.
Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity
IMCIVREE becomes first therapy approved in both US and Europe for acquired hypothalamic obesity, targeting adults and children 4+ with hypothalamic injury.
Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available
Vanda Pharmaceuticals' NEREUS (tradipitant) is now commercially available in the US, marking the first new prescription motion sickness treatment in over 40 years.
MRM Health's MH002 Receives FDA Fast Track Designation for Ulcerative Colitis Treatment
MRM Health's lead microbiome therapeutic MH002 granted FDA Fast Track status for mild-to-moderate ulcerative colitis, accelerating development timeline.
Cadrenal Therapeutics CAD-1005 Gets FDA Guidance for Phase 3 Trial in Heparin-Induced Thrombocytopenia
Cadrenal Therapeutics receives FDA guidance to advance CAD-1005 to Phase 3 for HIT after Phase 2 showed 25% reduction in blood clots when added to standard care.
Teva Acquires Emalex Biosciences for $700M to Gain First-in-Class Tourette Syndrome Drug Ecopipam
Teva's $700M acquisition of Emalex adds NDA-ready ecopipam, a first-in-class dopamine D1 antagonist for pediatric Tourette syndrome with FDA Fast Track status.
Viking Therapeutics VK2735 Phase 3 Obesity Trials Fully Enrolled as Company Reports Q1 2026 Results
Viking Therapeutics advances VK2735 obesity treatment with fully enrolled Phase 3 trials and $603M cash position, oral formulation trial expected Q4 2026.
Novo Nordisk's Denecimig Shows Significant Bleeding Reduction in Hemophilia A Phase 3 Trial Published in NEJM
Denecimig (Mim8) significantly reduced annualized bleeding rates in hemophilia A patients regardless of inhibitor status in pivotal FRONTIER2 study.
Perimeter Medical's Claire OCT+AI Receives FDA Approval for Breast Cancer Surgery Margin Assessment
Perimeter Medical's Claire OCT+AI becomes first FDA-approved AI-enabled device for real-time breast cancer margin assessment during surgery at ASBrS 2026.
Regeneron Announces Free Gene Therapy Otarmeni for Rare Hearing Loss in U.S. Government Agreement
Regeneron will provide Otarmeni gene therapy for free in the U.S. under new government agreement to lower drug costs for rare genetic hearing loss patients.
Inflation Reduction Act Drug Pricing: Impact on FDA Negotiations & Innovation 2026
The Inflation Reduction Act reshapes drug pricing strategies for diabetes treatments, influencing FDA negotiations and future pharmaceutical innovation by 2026.
Clinical Research Centers Brazil: Enhancing Trial Quality & Recruitment
Clinical Research Centers in Brazil are pivotal in improving trial quality and recruitment, ensuring effective drug development for conditions like diabetes.
EU HTA Regulation Impact: First Year Review on Drug Approval Timelines
This article reviews the first year of the EU HTA Regulation, analyzing its effects on drug approval timelines for therapies such as XYZ for cancer.
China Clinical Trial Regulations: Key Insights on NMPA Reforms 2024
Discover key insights on the 2024 NMPA reforms in China, shaping clinical trial regulations and their implications for drug development in oncology and rare diseases.