Regeneron Pharmaceuticals has received a positive opinion from the European Medicines Agency’s human medicines committee for ...

Eli Lilly’s Jaypirca (pirtobrutinib) has been recommended by the European Medicines Agency’s (EMA) human medicines committee ...

AbbVie (NYSE:ABBV) recently announced the availability of its drug SKYRIZI® in Canada for treating adults with ulcerative ...

Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing ...

The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...

Italfarmaco S.p.A. today announced a comprehensive update on the regulatory and clinical advancements for givinostat, the ...

Getting patients access to treatments they need – without which they will die – is the ‘biggest burden of my life’, says Prof ...

Q4 2024 Earnings Call Transcript March 5, 2025 Ocugen, Inc. reports earnings inline with expectations. Reported EPS is $-0.05 EPS, expectations were $-0.05. Operator: Good morning, and welcome to ...

US FDA & EMA grant orphan drug designation to Bioxodes’ haemorrhagic stroke therapeutic candidate, BIOX-101: Gosselies, Belgium Thursday, March 6, 2025, 15:00 Hrs [IST] Bioxodes ...

Ocugen Inc (OCGN) outlines pivotal trial progress and financial strategies while navigating increased expenses and market ...

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® ...

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...