The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...
Gilead (GILD) announced that the European Medicines Agency has validated for parallel accelerated review the company’s marketing authorization ...
Mitsubishi Tanabe Pharma (MTPC) today announced that the European Medicines Agency (EMA) has accepted for review the ...
| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...
Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively ...
MUNICH, Germany, and BASILDON, UK I February 13, 2025 I LINDIS Biotech GmbH, a clinical stage biopharmaceutical company with a proprietary multi-specific ...
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
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GlobalData on MSNEU reshapes HTAs: is the industry ready for it?New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
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