Articles by Matteo Ricci
CRISPR Therapeutics Reports Q1 2026 Results as CASGEVY Gene Therapy Gains Global Regulatory Approval
CRISPR Therapeutics reports Q1 2026 financial results highlighting CASGEVY's approval in 10+ countries for sickle cell disease and beta thalassemia treatment.
FDA Approves Auvelity for MDD: A New Antidepressant Option
The FDA has granted approval for Auvelity, a new oral medication for major depressive disorder (MDD) in adults. This approval introduces a novel treatment option with a distinct mechanism of action and a reported rapid onset of therapeutic effect.
FDA Approves Auvelity for MDD: Axsome Therapeutics' New Antidepressant
The FDA has granted approval for Auvelity, a new oral antidepressant developed by Axsome Therapeutics, to treat major depressive disorder (MDD) in adults. This marks a significant advancement in mental health treatment, offering a novel mechanism of action and potentially rapid symptom relief.
uniQure AMT-130 Gene Therapy Advances Toward UK Approval for Huntington's Disease Treatment
uniQure completes successful UK MHRA pre-submission meeting for AMT-130 Huntington's disease gene therapy, targeting Q3 2026 marketing authorization application.
Cerus Corporation INTERCEPT Blood System Advances Through European Regulatory Review and Phase 3 Trials
Cerus Corporation's INTERCEPT Blood System progresses through European regulatory review while Phase 3 RedeS trial readout and new INT200 device submission planned.
NMPA Approval Lung Cancer Immunotherapy: PD-1/PD-L1 Combo Trends 2025
This article delves into the NMPA's approval landscape for lung cancer immunotherapy, highlighting the emerging trends of PD-1/PD-L1 combination therapies by 2025.
African Medicines Agency Implementation: Transforming Regulatory Harmonization & Market Access
The African Medicines Agency is set to revolutionize regulatory processes, ensuring faster market access for vital medicines across the continent.
EMA Conditional Approval Pathway: Insights from Repotrectinib Oncology Approval
This article delves into the EMA Conditional Approval Pathway, highlighting key insights from the oncology approval of Repotrectinib for advanced cancer treatment.
X4 Pharmaceuticals Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment in EU
X4 Pharmaceuticals announces European Commission approval for XOLREMDI (mavorixafor), the first authorized treatment for WHIM syndrome patients in the EU.
EMA Conditional Marketing Authorizations: 5-Year Review of Oncology Drug Approvals
This article reviews the EMA's conditional marketing authorizations over the past five years, focusing on oncology drugs and their impact on cancer treatment accessibility.
SAHPRA accelerated approval oncology: What You Need to Know
Learn about SAHPRA's accelerated approval process for oncology, which expedites access to essential cancer treatments, including Pembrolizumab.
LATAM Oncology Clinical Trials: Expansion Trends & Success Factors 2024
Discover the latest trends in LATAM oncology clinical trials for 2024, highlighting drug innovations and critical factors driving success in cancer research.
NMPA Data Integrity Requirements: What Foreign Pharma Must Know in APAC
Understanding NMPA data integrity requirements is crucial for foreign pharmaceutical companies seeking to navigate the APAC market effectively.
NICE Technology Appraisals 2026: Impact on UK Pharmaceutical Market Access
NICE Technology Appraisals 2026 will significantly influence the UK pharmaceutical market, shaping access for drugs like XYZ in cancer therapy.
VivoSim Labs Launches AI Tool to Predict Drug-Induced Diarrhea Without Animal Testing
VivoSim Labs unveils AI prediction platform using human intestinal models to forecast gastrointestinal toxicity, eliminating need for animal testing.
Advanced Bifurcation Systems Acquires Svelte Medical Systems in Major Coronary Stent Deal
Advanced Bifurcation Systems Inc. acquires Svelte Medical Systems, expanding its coronary angioplasty portfolio with drug-eluting stents and regulatory approvals.
Zentiva Appeals EU Court Decision on Urban Wastewater Directive Affecting Generic Medicine Access
Zentiva and generic drugmakers challenge EU Urban Wastewater Directive at CJEU, citing concerns over patient access and medicine affordability in Europe.
Crinetics Pharmaceuticals Receives EU Approval for PALSONIFY (Paltusotine), First Oral Daily Acromegaly Treatment
Crinetics Pharmaceuticals announces European Commission approval of PALSONIFY (paltusotine), the first once-daily oral therapy for acromegaly in adults.
Pharma Supercomputer: Eli Lilly and NVIDIA’s AI-Powered Breakthrough
Eli Lilly and NVIDIA have partnered to build the pharmaceutical industry's most powerful supercomputer. This AI-driven innovation aims to accelerate drug discovery and development, enhancing computational research capabilities globally.
African Medicines Agency: Harmonizing Regulatory Standards to Boost Pharma Access
The African Medicines Agency aims to streamline regulatory processes, improving access to vital medications such as antiretrovirals and boosting public health across Africa.