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 ...
The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...
Post-authorisation safety studies (PASS) are often seen simply as a regulatory necessity, a checkbox that ensures ongoing ...
Vertex Pharmaceuticals demonstrates resilience with robust CF franchise, new approvals, and diversification efforts. Read why ...
Italfarmaco S.p.A. today announced a comprehensive update on the regulatory and clinical advancements for givinostat, the ...
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical ...
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® ...
The Gross Law Firm issues the following notice to shareholders of GSK plc . Shareholders who purchased shares of GSK during the ...
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 ...
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