Drug Approvals
Page 2 • 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: 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.
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 Approval for XOLREMDI (Mavorixafor), First WHIM Syndrome Treatment in EU
Norgine's XOLREMDI becomes the first authorized treatment for WHIM syndrome in Europe, marking a breakthrough for ultra-rare immunodeficiency patients.
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.
Henlius and Organon's POHERDY Becomes First Pertuzumab Biosimilar Approved in Europe
European Commission approves POHERDY as first pertuzumab biosimilar in Europe, offering cost-effective alternative to PERJETA for breast cancer treatment.
EMA Conditional Marketing Authorization: Impact on Oncology Patient Access in EU
This article examines the impact of EMA Conditional Marketing Authorization on improving access to innovative oncology drugs, such as XYZ, for patients in the EU.
EU HTA Regulation Impact: Effects on Rare Disease Drug Approvals & Market Access
This article examines how the EU HTA Regulation influences the approval and market access of rare disease drugs, focusing on Zolgensma for spinal muscular atrophy.
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.
EMA Conditional Marketing Authorization: Oncology Approvals & EU Patient Access
This article delves into the EMA's Conditional Marketing Authorization process, focusing on oncology drug approvals and their impact on patient access in the EU.
MHRA post-Brexit drug approval: Market Impact on UK-EU Pharma Firms
This article examines how the MHRA's post-Brexit drug approval process affects UK-EU pharmaceutical firms, highlighting the implications for drugs like XYZ for chronic pain.
Cytokinetics MYQORZO (Aficamten) Takes Center Stage at European Society of Cardiology Heart Failure 2026 Congress
Cytokinetics presents nine studies on MYQORZO (aficamten) at ESC Heart Failure 2026, including late-breaking science on the newly approved oHCM treatment.
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.