You are here: Industry Insights > EC

News List

After 7 years, EC grants approval for Merck KGaA’s MS drug pharmafile
August 28, 2017
Pharmacovigilance is a science of understanding drug safety through identification, assessment, and prevention of adverse drug reactions (ADRs).
FDA, EMA and EC sign new confidentiality commitment pharmatimes
August 25, 2017
The US Food and Drug Administration can now share non-public and commercially confidential information, including trade secrets relating to medicines inspections, with EU regulators after the parties signed a new commitment.
Brilique (ticagrelor) new formulation gains European approval europeanpharmaceuticalreview
May 26, 2017
The European Commission (EC) has granted marketing authorisation for AstraZeneca’s Brilique (ticagrelor) orodispersible tablets (ODT) as a new method of treatment administration.
EUSA Pharma receives EC approval for dinutuximab beta antibody to treat neuroblastoma pharmaceutical-technology
May 11, 2017
EUSA Pharma has secured European Commission (EC) approval for the antibody ch14.18/CHO, (dinutuximab beta) to be used in treating high-risk neuroblastoma in patients older than a year.
EC grants marketing authorisation for Actelion’s Ledaga to treat MF-CTCL pharmaceutical-technology
March 09, 2017
The European Commission (EC) has granted marketing authorisation for 160mcg of Actelion’s Ledaga (chlormethine gel) to treat mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).
EC amends marketing authorisation for Pharming’s Ruconest to include self-administration pharmaceutical-technology
January 18, 2017
The European Commission (EC) has amended the marketing authorisation for Netherlands-based Pharming Group’s Ruconest (recombinant C1 esterase inhibitor) to include self administration using the Ruconest administration kit.

Previous page 1 2 3 4 5 6 7 8 9 10 11 12 Next page