In a similar manner, member states must now pool their resources to address their shared geoeconomic concerns. To achieve ...

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

CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three ...

is pleased to announce that the European Medicines Agency (the “EMA”) has granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this ...

EBR Systems is among ASX healthcare stocks with upcoming catalysts, expecting feedback on a FDA substantive review expected ...

Positive results from completed Phase 2 study of mavorixafor in chronic neutropenia (CN) announced todayPivotal Phase 3 trial of mavorixafor in ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and ...

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

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 ...

Relutrigine has received Orphan Drug Designation (ODD) and Rare Pediatric Designation (RPD) from the FDA, and ODD from the European Medicines Agency (EMA) for the treatment of SCN2A-DEE and SCN8A-DEE.

A European-style pharmaceutical regulatory body will be created in Ukraine.Deputy Health Minister Maryna Slobodnichenko said this in an interview with 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 ...