European Medicines Agency (EMA) has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU). The pilot programme ...

The whistleblower lawsuit, filed by a sales representative for a competing medical device company ... Battle Over Orphan Drug Program Leaves Patients in the Lurch Lore Wilkinson, a 91-year ...

Manufacturers of high-risk medical devices intended for the treatment of a rare condition should apply for advice via the ongoing pilot programme to support orphan medical devices. EMA provides the ...

The European Medicines Agency (EMA) has designated allopurinol as the first orphan drug for the treatment of Marfan syndrome, ...

We explore the various challenges facing orphan medicines entering the European market and offer solutions to help improve patient access. There are an estimated 7,000 rare diseases worldwide for ...

The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles ...

SCLC is a deadly condition that represents a significant unmet medical need due to the limited number of treatment options available to patients with this aggressive form of cancer. Two-thirds of ...

NEW YORK, NY / ACCESSWIRE / April 23, 2024 / Laxxon Medical, a leading 3D screen printing platform technology company, announced today its participation in the World Orphan Drug Congress USA 2024 ...