Articles by Isabella Cruz
FDA Approves Travere's FILSPARI for FSGS Treatment in Adults and Children 8+
Travere Therapeutics receives FDA approval for FILSPARI to reduce proteinuria in FSGS patients aged 8 and older, expanding rare kidney disease treatment options.
Axoft Raises $55M Series A to Advance Brain-Computer Interface Clinical Trials Globally
Axoft secures $55M Series A funding led by C.P. Group Innovation to advance bio-inspired brain-computer interface technology into global clinical trials.
FDA Approval of Elarekig: What You Need to Know
Elarekig has received FDA approval for advanced melanoma treatment, offering new hope for patients. Find out essential details about this breakthrough therapy.
Insilico Medicine's Rentosertib Inhalation Solution Receives IND Clearance for First AI-Driven Direct-to-Lung Clinical Trial
Insilico Medicine's AI-discovered Rentosertib inhalation solution gets IND clearance for direct-to-lung delivery, marking a milestone in AI drug development.
Yangtze River Pharmaceutical Group Quadruples International Revenue in 2025 Global Expansion
Yangtze River Pharmaceutical Group reports 4x international revenue growth, doubling global partnerships while exporting 100+ products to 40+ countries.
HTA Outcomes Oncology Drugs: EU Regulation Impact on Germany, France, Italy
This article examines the effects of EU regulations on HTA outcomes for oncology drugs, focusing on implications for Germany, France, and Italy.
ANVISA risk-based inspection: What You Need to Know
Learn about ANVISA's risk-based inspection approach, crucial for maintaining drug safety and efficacy in the pharmaceutical industry.
African Medicines Agency progress: What You Need to Know
Learn about the African Medicines Agency's advancements in drug regulation, focusing on improving access to essential medicines and public health in Africa.
ANVISA Approves Trastuzumab Deruxtecan: What You Need to Know
Trastuzumab Deruxtecan has been approved by ANVISA for the treatment of HER2-positive breast cancer, offering new hope for patients and healthcare providers.
Aquestive Therapeutics Faces Class Action Lawsuit Over Anaphylm Drug Approval Timeline Claims
Investors file class action against Aquestive Therapeutics alleging misleading statements about Anaphylm sublingual film approval timeline and January 2026 PDUFA date.
ANVISA Approves Emtricitabine + Tenofovir Fumarate: Market Impact in Brazil
The recent ANVISA approval of Emtricitabine + Tenofovir Fumarate marks a pivotal moment for HIV treatment options in Brazil, influencing market dynamics.
MorphoSys' MINJUVI (Tafasitamab) Approved in Australia for Relapsed/Refractory Follicular Lymphoma
Australia approves MINJUVI (tafasitamab) as first chemotherapy-free dual-targeted immunotherapy for relapsed/refractory follicular lymphoma patients.
WuXi Biologics Receives South Korea GMP Certification for Bispecific Antibody Manufacturing
WuXi Biologics secures South Korea MFDS GMP certification for three facilities, enabling commercial manufacturing of bispecific antibody therapeutics.
Australia's TGA Updates Therapeutic Sunscreen Regulatory Framework for Enhanced Consumer Protection
Australia's TGA provides comprehensive guidance on therapeutic sunscreen regulation, covering application processes, market authorization, and compliance requirements.
FDA Approval Elarekig: What You Need to Know About TRD Treatment
Elarekig has received FDA approval for treating treatment-resistant depression (TRD), offering new hope for patients seeking effective solutions.