EMA’s 2022 Annual Report published
The European Medicines Agency (EMA) publishes every year an annual report providing an overview of EMA’s work together with the European medicines regulatory network. In these annual reports you can…
FDA Approves Topical Gene Therapy for Dystrophic Epidermolysis Bullosa Wound Treatment
The approval of the first topical gene therapy for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) marks a significant milestone in the field of dermatology and…
Reform of the EU pharmaceutical legislation for human medicines
On April 26th, 2023, the largest reform of the EU pharmaceutical legislation in over 20 years by the European Commission has been published and aims to make the legal framework…
New FDA-approved Cell Therapy for Blood Cancers to Reduce Infection Risk
The FDA has approved a new cell therapy for patients with blood cancers, known as Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery…
PRIME: EMA’s Priority Medicines scheme has new features that improve it
The European Medicines Agency (EMA) is introducing a number of new features to the PRIority MEdicines (PRIME) scheme to strengthen its support for the development of medicines in areas of…
New FDA Guidance on Clinical Trails Recommendations for Accelerated Approvals
Last week, the U.S. Food and Drug Administration (FDA) released a new draft guidance regarding clinical trials considerations to support accelerated approvals: Clinical Trial Considerations to Support Accelerated Approval of…
2023 Work Plan of EMA’s Committee for Advanced Therapies Medical Products (ATMPs)
Recently, the European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) has published its 2023 Work Plan. In this report the Committee highlights the actions and activities on the regulation…
EMA’s 2022 Highlights on Human Medicines and Advanced Therapies
Recently, the European Medicines Agency (EMA) has published its Human Medicines Highlights 2022 report, a report including figures on the authorisation of medicines and a selection of new treatments that…
OTAT Town Hall events and advice on gene therapy trials
The Office of Tissues and Advanced Therapies (OTAT) from the FDA’s Center for Biologics Evaluation and Research (CBER) hosted last week a town hall answering stakeholder questions related to the…
Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications
On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications (CTA). It will serve as the single-entry point for…
