Recall

Dr. Reddy’s Laboratories Ltd. has initiated a nationwide recall in the United States for a specific batch of Levetiracetam in 0.75% Sodium Chloride Injection,...

Amgen Technology (Ireland) UC has officially retracted its marketing authorization application for the biosimilar medicine Skojoy in the European Union. The withdrawal took effect...

Since the FDA's recent approval of elacestrant (Orserdu) for breast cancer treatment, a surge in adverse event reports has emerged, prompting a closer examination...

The European Commission granted orphan designation to magrolimab, a humanised monoclonal antibody targeting CD47, for treating acute myeloid leukaemia (AML). This designation acknowledges the...

The U.S. Food and Drug Administration (FDA) has intensified its efforts to ensure the integrity of medical device submissions and safeguard consumers from unapproved...

Brainvectis, a French biotechnology company, received orphan designation from the European Commission for its innovative treatment targeting Huntington's disease. This designation, granted on April...

Orphix Consulting GmbH withdrew Upifitamab rilsodotin from the EU Register of orphan medicinal products in February 2025. Initially designated on December 9, 2022, this...

Theranexus S.A.S., a pharmaceutical company based in France, secured orphan designation from the European Commission for its innovative treatment, trehalose, targeting neuronal ceroid lipofuscinosis....

The European Commission has officially granted orphan status to venetoclax, a promising treatment developed by AbbVie Deutschland GmbH & Co. KG, for patients battling...

Abbvie Deutschland GmbH & Co. KG has successfully obtained orphan designation from the European Commission for Venetoclax, a promising treatment targeting mantle cell lymphoma...

The European Medicines Agency (EMA) has unveiled its annual compilation of human medicinal products withdrawn from the EU market throughout 2024. This meticulous list...

Starting July 2024, the European Medicines Agency (EMA) will eliminate the need for urgent safety notifications. This shift aims to simplify the regulatory landscape...

The European Commission has officially recognized Esteve Pharmaceuticals' innovative gene therapy as an orphan medicinal product for treating mucopolysaccharidosis type IIIB, also known as...

Amitriptyline, initially recognized as an orphan medicinal product for treating erythromelalgia, has been removed from the European Union's orphan register as of January 2025....

The European Medicines Agency (EMA) has retracted the orphan designation for a novel treatment targeting hereditary angioedema, following the sponsor's request. Initially granted on...