EMA validates indication extension application for Aspaveli® for treatment of C3G and primary IC-MPGN
Sobi® and Apellis Pharmaceuticals today announced the European Medicines Agency (EMA) has validated an indication extension application for Aspaveli® (pegcetacoplan) for the treatment of C3 ...
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
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 ...
Medscape7d
EMA Launches Review of Finasteride for Suicidal Ideation
The European Medicines Agency has started a review of medicines containing finasteride and dutasteride following concerns ...
Pharmabiz3h
Sobi & Apellis Pharma announces EMA validates indication extension application for Aspaveli for treatment of C3G and primary IC-MPGN
Stockholm, Sweden Saturday, February 22, 2025, 09:00 Hrs [IST] ...
EMA creates advice portal for some high-risk medical devices
The European Medicines Agency said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies.
NL Times7d
Russian spies had access to EMA systems for four months in 2020 hack: report
Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...
Apellis and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN
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) ...
Managed Healthcare Executive1d
FDA, EMA See Differences in Cell and Gene Therapy Trial Data
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social media platform that some have ...
Pharm Exec26d
EMA Takes Break From X, Joins Bluesky
The government agency says X no longer suits its communication needs. On Friday, January 24, 2025, the European Medicines Agency (EMA) announced it was taking a break from X (formerly known as Twitter ...