Drug Approvals
Page 3 • 12 itemsTrack global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.
EMA Conditional Approval Pathway: Case Study on Repotrectinib Oncology Drug
This article delves into the EMA Conditional Approval Pathway, highlighting the case study of Repotrectinib for treating ROS1-positive oncology patients.
![EMA Biosimilar Approvals 2024: Impact on [Specific Drug] Market & Pricing](/uploads/articles/ema-biosimilar-approvals-specific-drug-market-analysis-2024.webp)
EMA Biosimilar Approvals 2024: Impact on [Specific Drug] Market & Pricing
Discover how the 2024 EMA biosimilar approvals will affect the market dynamics and pricing strategies for [Specific Drug] used in treating [Indication].
EMA Issues Positive Opinion for Rexatilux (Ranibizumab) Eye Treatment
European Medicines Agency issues positive opinion for Rexatilux ranibizumab, advancing potential new eye treatment option for European patients.
EMA Issues Positive Opinion for Redemplo (Plozasiran) in European Drug Approval Process
European Medicines Agency issues positive opinion for Redemplo (plozasiran) marking significant step toward EU market authorization for this novel therapy.
EMA Issues Positive Opinion for Viatris' Palbociclib Generic Cancer Treatment
European Medicines Agency issues positive opinion for Viatris' generic palbociclib, potentially expanding access to this important breast cancer treatment.
EMA Issues Positive Opinion for Cenrifki (Tolebrutinib) Multiple Sclerosis Treatment
European Medicines Agency issues positive opinion for Cenrifki (tolebrutinib), a potential new oral treatment for multiple sclerosis patients.
EMA Recommends Approval of Plozasiran (Redemplo) for Rare Triglyceride Disorder FCS
European Medicines Agency recommends plozasiran (Redemplo) for marketing authorization to treat adults with familial chylomicronaemia syndrome in EU.
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.
MHRA post-Brexit drug approval: Market Access & Pricing Impact Analysis
This article analyzes the implications of MHRA's post-Brexit drug approval process on market access and pricing strategies for therapies like XYZ for cancer.
EMA Conditional Marketing Authorization: Impact on Oncology Drug Access in EU
This article examines the impact of EMA Conditional Marketing Authorization on improving access to oncology drugs, specifically focusing on drug XYZ for cancer treatment in the EU.
Dupixent Becomes First Biologic Approved for Chronic Spontaneous Urticaria in Children Ages 2-11
Sanofi and Regeneron's Dupixent receives FDA approval as the first biologic treatment for pediatric chronic spontaneous urticaria in children 2-11 years old.
Ipsen Receives EU Approval for Ojemda (Tovorafenib) to Treat Pediatric Brain Cancer with BRAF Mutations
Ipsen secures conditional EU marketing authorization for Ojemda (tovorafenib) to treat pediatric low-grade glioma with BRAF alterations in patients 6 months and older.