Press Releases
Allergan Receives FDA Approval of TEFLARO for Pediatric Patients
Label Now Includes New Data on Use of TEFLARO in Pediatric Patients 2 Months of Age to Less than 18 Years of Age with...
Press Releases
EU Grants Approval to Remicade Biosimilar Flixabi
The European Commission (EC) granted marketing authorization in the European Union (EU) for FLIXABI®, an infliximab biosimilar referencing Remicade®i. FLIXABI was developed by Samsung Bioepis,...
Press Releases
AbbVie, Eisai and EA Pharma receive additional approval for...
AbbVie , Eisai Co Ltd. and its subsidiary EA  Pharma Co Ltd. announced the additional approval for a new dosing regimen of Humira® Pre-filled Syringe...
Press Releases
Merck receives positive CHMP opinion for Zepatier in the...
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval...
Press Releases
The EC grants the European marketing authorization to StrimvelisTM
GlaxoSmithKline (GSK), Fondazione Telethon (Telethon) and Ospedale San Raffaele (OSR) announced that the European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy...
Press Releases
Positive CHMP opinion in EU for saxa/dapa (saxagliptin and...
AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval...
Press Releases
European CHMP Adopts Positive Opinion for Gilead’s Epclusa for...
Gilead Sciences Inc announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted...
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