PathAI, a global leader in AI-powered pathology, today announced that the European Medicines Agency (EMA) Committee for ...

Mía had dystrophic epidermolysis bullosa, better known as butterfly skin due to the extreme fragility of this tissue in ...

The European Medicines Agency (EMA) has approved an additional 2 mL pre-filled pen option for subcutaneous administration of Takeda’s Takhzyro (lanadelumab), aimed at treating hereditary ...

A study has found that a single dose of the Imvanex vaccine provides protection against Mpox with 84% effectiveness. For people with HIV, however, a single dose of the vaccine fails to offer ...

When comparing the FDA and EMA, we found that many of the calculations that determine this relative speed have used time of approval and time of market authorization, interchangeably. This ...

Takeda (TAK) announced that the EMA has approved an additional two mL pre-filled pen option for Takhzyro for subcutaneous administration in adolescents and adult patients with Hereditary Angioedema.

SUSTAIN was the basis for FDA approval and European Medicines Agency (EMA) approval for crizanlizumab for the prevention of vaso-occlusive crises in patients ages 16 years and older with sickle ...

In December 2024, the National Comprehensive Cancer Network® (NCCN) added AUCATZYL (obecabtagene autoleucel) to its Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for the treatment of ...

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU ... of the European Medicines Agency (EMA) based its positive opinion on ...

A new EMA approval has expanded the use of Vertex Pharma’s cystic fibrosis therapy Symkevi to children as young as six if they have specific gene mutations. The regulator has given a green light ...

The European Medicines Agency (EMA) has issued a warning about the dangers of unregulated advanced therapy medicinal products (ATMPs) being illegally offered to patients in Europe. ATMPs encompass ...