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EMA
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Nitrosamine Impurities
Addressing the Evolving Nitrosamine Contamination Issue
PAO-09-23-CL-07
Alternative Excipient
Preparing Today for a Potential Ban on Titanium Dioxide in Pharmaceutical Drug Products
PAO-08-23-CL-01
Clinical Trials
Early Reports of Positive Experiences with EMA’s New Clinical Trials Information System
PAO-02-23-CL-02
European DCTs
Exploring Challenges and Considerations for Operationalizing DCTs in the European Union
PAO-09-022-CL-07
Regulatory Data
Data-Based Regulatory Submissions: What DADI Means for You
PAO-05-022-CL-08
COVID-19 Vaccine
EMA Starts Evaluating Use of COVID-19 Vaccine Comirnaty in Young People Aged 12 to 15
PR-M05-21-005
Glocalization
From Regulatory Convergence to Global Regulatory Harmonization
PAP-Q3-19-NI-004
Novel Therapies
Q: What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?
PAP-Q2-19-NI-007
Regulatory
Are EMA and FDA Decisions Diverging?
PAO-M08-19-NI-037
Phase III
Inovio Receives European Medicines Agency Certification For Quality and Non-Clinical Data for Its Phase 3 Product, VGX-3100
PR-M05-19-NI-022
Pain Management
Heron Announces European Medicines Agency Validation of Marketing Authorisation Application for HTX-011 for Postoperative Pain Management
PR-M04-19-NI-026
Positive Opinion
Autologous Gene Therapy Receives Positive Opinion from EMA Committee
PAO-M04-19-NI-005
GMP
WuXi Biologics Receives EMA GMP Certificates
PR-M03-19-NI-061
Pediatric
Novo Nordisk Files for a Label Update for Fiasp® to the EMA and the FDA Seeking Approval for Use in Children and Adolescents
PR-M03-19-NI-007
Drug Development
EMA Committee Recommends Approval of Teva’s Anti-CGRP Treatment for Migraines
PAO-M02-19-NI-003
Brexit
EMA Will Soon Operate from Amsterdam
PAO-M02-19-NI-001
EMA Approval
Eiger Announces PRIME Designation Granted by European Medicines Agency for Lonafarnib for Treatment of Hepatitis Delta Virus Infection
PR-M12-18-NI-078
Drug Development
EMA Recommends Approval of the First Oral Drug for Sleeping Sickness
PAO-M11-18-NI-019
Biosimilars
Herceptin Biosimilar Gets Positive Opinion in Europe
PAO-M10-18-NI-024
Positive Opinion
Lilly Receives Positive CHMP Opinion for Emgality™ (galcanezumab) for the Prophylaxis of Migraine in Adult
PR-M09-18-NI-092
Orphan Drug
Arrowhead Receives Positive EMA Opinion on Orphan Designation for ARO-AAT for Treatment of Congenital Alpha-1 Antitrypsin Deficiency
PR-M06-18-NI-097
Approval
U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
PR-M06-18-NI-036
Oncology
New Breast Cancer Drug Accepted for Review by EMA
PAO-M04-18-NI-010
Diabetes
Sanofi’s Sotagliflozin Accepted for Review by EMA
PAO-M04-18-NI-006
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