Articles by Dr. Hannah O'Connor
FDA Approves Auvelity: A New Option for MDD
The FDA has approved Auvelity, a new oral antidepressant combining bupropion and dextromethorphan, for the treatment of major depressive disorder (MDD) in adults. Manufactured by Axsome Therapeutics, this approval marks a significant advancement in MDD treatment options.
Auvelity FDA Approval: New MDD Treatment Option
The FDA has approved Auvelity, a new oral treatment for major depressive disorder (MDD) in adults, marking a significant advancement in mental health therapeutics. Manufactured by Axsome Therapeutics, this approval offers a novel option for patients seeking relief from MDD.
Moderna FDA Talks Focus on Phase 4 COVID Vaccine Data
Moderna is currently in discussions with the U.S. Food and Drug Administration (FDA) regarding the submission of Phase 4 data for its COVID-19 vaccine, mRNA-1273. These talks are crucial for understanding the vaccine's ongoing real-world effectiveness and post-marketing surveillance.
Osimertinib FDA Approval Expands Early-Stage NSCLC Treatment
The FDA has approved osimertinib (Tagrisso) for adjuvant treatment of early-stage NSCLC, marking a milestone for AstraZeneca and expanding treatment options. Learn about the clinical data, market impact, and investment implications.
Telix Pharmaceuticals' TLX101-Px (Pixlumi) Brain Cancer Imaging Drug Accepted for European Review
Telix Pharmaceuticals' TLX101-Px (Pixlumi) glioma imaging drug enters 210-day European regulatory review after MAA acceptance, targeting brain cancer diagnosis.
EU Pharmaceutical Legislation Reform: Impact on Generics & Biosimilars 2026-27
The upcoming EU pharmaceutical legislation reform will significantly affect generics and biosimilars, shaping the future of drug access and innovation in 2026-27.
European Commission Approves POHERDY, First Pertuzumab Biosimilar in Europe by Henlius and Organon
EC grants marketing authorization for POHERDY (pertuzumab), the first approved biosimilar to PERJETA in Europe, developed by Henlius Biotech and Organon.
Norgine Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment
Norgine's XOLREMDI becomes first authorized treatment for WHIM syndrome in Europe, marking breakthrough for ultra-rare immunodeficiency patients.
EMA Establishes Expert Panel to Strengthen COVID-19 mRNA Vaccine Trust Including Spikevax and Comirnaty
European Medicines Agency forms international expert panel to enhance public confidence in COVID-19 mRNA vaccines including Spikevax and Comirnaty.
COFEPRIS Biosimilars Regulation: What You Need to Know in 2024
Learn about COFEPRIS's updated biosimilars regulations in 2024, focusing on safety, efficacy, and the impact on drugs like trastuzumab for breast cancer.
FDA Accelerated Approval Reforms: What You Need to Know for Oncology Market Access 2026
Understand the key changes in FDA Accelerated Approval reforms and their implications for oncology market access, including drugs like Keytruda by 2026.
Biosimilars in Japan: Market Growth and PMDA Regulatory Insights 2024
This article delves into the expanding biosimilars market in Japan, focusing on trastuzumab's role in cancer treatment and the latest PMDA regulatory updates for 2024.
SFDA Accelerated Approval Oncology: Impact on Innovative Drugs in Saudi Arabia
The SFDA's Accelerated Approval program significantly impacts the availability of innovative oncology drugs, such as Keytruda, for cancer patients in Saudi Arabia.
Solid Biosciences Receives European Orphan Drug Designation for SGT-003 Duchenne Muscular Dystrophy Treatment
Solid Biosciences secures European Commission orphan drug designation for SGT-003, advancing gene therapy development for Duchenne muscular dystrophy patients.
Mundipharma's REZZAYO (Rezafungin) Meets Primary Endpoint in Phase III ReSPECT Trial for Fungal Disease Prevention
Mundipharma announces positive Phase III ReSPECT trial results for REZZAYO (rezafungin) in preventing invasive fungal diseases in stem cell transplant patients.
GLP-1 Eating Disorder Risk: What You Need to Know
Recent concerns about GLP-1 receptor agonists like semaglutide highlight potential eating disorder risks. This article reviews current evidence, FDA stance, and safety considerations.
EMA CHMP Recommends Five New Medicines Including Tolebrutinib (Cenrifki) for Approval in April 2026
European Medicines Agency's CHMP committee recommended five new medicines for approval in April 2026, including tolebrutinib (Cenrifki) for multiple sclerosis treatment.
COFEPRIS Drug Approvals: Trends and Market Impact in Oncology 2025
This article analyzes COFEPRIS drug approvals in oncology, highlighting trends and market impacts for drugs like Pembrolizumab by 2025.
Pembrolizumab Expanded Label: KEYNOTE-826 Trial Transforms Advanced Cervical Cancer Care
The KEYNOTE-826 trial has led to pembrolizumab's expanded label, marking a significant advancement in the treatment of advanced cervical cancer.
Genomics Services Market to Reach $24 Billion by 2033 as Precision Medicine Adoption Accelerates
The global genomics services market is projected to grow at 11.2% CAGR through 2033, driven by precision medicine advances and digital health initiatives.