Orphan Designation offers 10 years of market exclusivity in Europe upon product approval, along with additional regulatory and commercial benefits Positions Neurizon to advance the development of ...

Neurizon has been buoyed by the receipt of a positive opinion from the European Medicines Agency in relation to its ... Read ...

The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick the ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for ...

J&J’s filing is based on results from the phase 3 AQUILA trial. Among 390 patients with high-risk smoldering multiple myeloma ...

China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western ...

Patient involvement in health policy is a patchwork across the EU. Putting the lived experience front and centre of policy-making was prioritised at a recent high-level policy event organised by the ...

The European Commission (EC) will decide in approximately two months. Last month, Novartis released new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta (ofatumumab ...

Vutrisiran treatment leads to a decrease in serum vitamin A levels. Supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients taking vutrisiran.

Astellas to withdraw European marketing authorization application for avacincaptad pegol to treat GA secondary to AMD: Tokyo Tuesday, October 29, 2024, 13:00 Hrs [IST] Astellas Ph ...

(Nasdaq: ALNY), the leading RNA interference (RNAi) therapeutics company, today announced the submission of a Type II Variation to the European Medicines Agency (EMA) for vutrisiran, an ...

Bayer has submitted an EMA application for darolutamide combined with ADT for metastatic hormone-sensitive prostate cancer. The Phase 3 ARANOTE trial showed darolutamide with ADT reduced ...