Gilead (GILD) announced that the European Medicines Agency has validated for parallel accelerated review the company’s marketing authorization ...
| Avoid common pitfalls in EU orphan drug market access—learn how local expertise can help navigate pricing, reimbursement, ...
Number 4: The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis ...
Biliary tract cancer is increasing in incidence and mortality across Europe, with more people under the age of 60 years old ...
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...
Continued strong commercial execution of the OGSIVEO launch in the U.S. with fourth quarter and full-year 2024 U.S. net product revenue for OGSIVEO of $61.5 million and $172.0 million, respectively.
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi ® (STO:SOBI) today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli ® (pegcetacoplan) ...
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...