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REVIO PHARMACEUTICAL CONSULTANTS
Read more about the article FDA Approves First Gene Therapy for Adults with Severe Hemophilia A

FDA Approves First Gene Therapy for Adults with Severe Hemophilia A

  • Post published:July 6, 2023

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…

Continue ReadingFDA Approves First Gene Therapy for Adults with Severe Hemophilia A
Read more about the article FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

  • Post published:July 3, 2023

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…

Continue ReadingFDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy
Read more about the article EMA’s Guideline on Comparability for Advanced Therapies

EMA’s Guideline on Comparability for Advanced Therapies

  • Post published:June 27, 2023

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…

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Read more about the article EMA’s 2022 Annual Report published

EMA’s 2022 Annual Report published

  • Post published:June 6, 2023

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…

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Read more about the article FDA Approves Topical Gene Therapy for Dystrophic Epidermolysis Bullosa Wound Treatment

FDA Approves Topical Gene Therapy for Dystrophic Epidermolysis Bullosa Wound Treatment

  • Post published:May 25, 2023

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…

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Read more about the article Reform of the EU pharmaceutical legislation for human medicines

Reform of the EU pharmaceutical legislation for human medicines

  • Post published:May 11, 2023

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…

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Read more about the article New FDA-approved Cell Therapy for Blood Cancers to Reduce Infection Risk

New FDA-approved Cell Therapy for Blood Cancers to Reduce Infection Risk

  • Post published:April 27, 2023

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…

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Read more about the article PRIME: EMA’s Priority Medicines scheme has new features that improve it

PRIME: EMA’s Priority Medicines scheme has new features that improve it

  • Post published:April 12, 2023

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…

Continue ReadingPRIME: EMA’s Priority Medicines scheme has new features that improve it
Read more about the article <strong>New FDA Guidance on Clinical Trails Recommendations for Accelerated Approvals</strong>

New FDA Guidance on Clinical Trails Recommendations for Accelerated Approvals

  • Post published:March 30, 2023

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…

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Read more about the article <strong>2023 Work Plan of EMA’s Committee for Advanced Therapies Medical Products (ATMPs)</strong>

2023 Work Plan of EMA’s Committee for Advanced Therapies Medical Products (ATMPs)

  • Post published:March 15, 2023

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…

Continue Reading2023 Work Plan of EMA’s Committee for Advanced Therapies Medical Products (ATMPs)
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Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)

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