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

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

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

The fact that the European Medicines Agency (EMA) advised against conditional approval adds to the cautious approach. Moreover, Agenus’s ongoing investigator-sponsored trials (ISTs) in the neoadjuvant ...

Interim analysis for Study 1 of Essential3 Phase 3 program for ulixacaltamide in essential tremor (ET) confirmed for Q1 2025; NDA filing ...

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

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received a GMP certificate from the European Medicines Agency for its ...

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 ...

While the final decision is set for next month, biotech player Neurizon’s (ASX:NUZ) hopes have been lifted with a view ...

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 ...