Recently, the FDA has given its approval to Roctavian from BioMarin Pharmaceutical Inc. It is an adeno-associated virus vector-based gene therapy intended to treat adults who have severe Hemophilia A…
The FDA has officially granted approval on June 22nd 2023 to Elevidys, marking it as the first gene therapy for addressing Duchenne muscular dystrophy (DMD) in paediatric patients aged 4…
Today, from Revio, we would like to share an overview on the EMA’s scientific guideline “Questions and answers: Comparability considerations for Advanced Therapy Medicinal Products (ATMP)”. Comparability remains an important…
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…
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…
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…
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…
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…
Last week, the U.S. Food and Drug Administration (FDA) released a new draft guidance regarding clinical trials considerations to support accelerated approvals: Clinical Trial Considerations to Support Accelerated Approval of…
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…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)