European Commission
Boehringer, Teva, others hit with EU fines for drug-ingredient cartel
Five pharmaceutical companies, including the prominent global firm Boehringer Ingelheim, find themselves in the midst of a regulatory storm, facing ...
Roche’s Evrysdi Illuminates Hope: EC Expands Approval for SMA Infants
To provide a brighter future for infants battling spinal muscular atrophy (SMA), Roche has unveiled a momentous development. The European ...
EC Approves Pfizer’s Abrysvo, Only RSV vaccine in EU for adults and infants
Pfizer has just received approval from the European Commission (EC) for its groundbreaking vaccine, Abrysvo. This vaccine, targeting the respiratory ...
Aquipta Gets the Nod for Migraine Prevention in European Adults, courtesy of AbbVie
AbbVie has made a significant stride in the realm of migraine management with the European Commission’s green light for Aquipta ...
Gilead’s Trodelvy for Pre-Treated HR+/HER2- Metastatic Breast Cancer Receives European Commission Approval
Source – Gilead Gilead Sciences, has received approval from the European Commission (EC) for the use of Trodelvy (sacituzumab govitecan) ...
A New Hope for Children and Teens with gMG: Soliris Gets EU Approval
Source – AstraZeneca The European Union (EU) has granted approval for the expanded use of Soliris (eculizumab) to treat refractory ...
Merck’s Gefapixant Receives Positive EU CHMP Opinion
Source – Merck MSD has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has ...
AbbVie’s Epcoritamab (EPKINLY) Receives Positive CHMP Opinion for DLBCL Treatment
Source – AbbVieAbbVie and Genmab’s potential blockbuster drug epcoritamab has received a favorable recommendation for conditional approval in the EU ...
Roche’s Columvi (glofitamab) for patients with R/R diffuse large B-cell lymphoma has received approval from the European Commission
Source – Roche On 11 July 2023 Roche announced that the European Commission (EC) has given conditional approval for Columvi ...
Novavax’s Covid vaccine receives a unanimous EU approval
Source – Novavax Novavax received full Marketing Authorization (MA) from the European Commission for its COVID-19 vaccine, Nuvaxovid (NVX-CoV2373). This ...
European Commission Grants Approval for ORKAMBI to Treat Cystic Fibrosis in Children Aged 1 to <2 Years
Source – Vertex Pharmaceuticals On July 5, 2023, Vertex Pharmaceuticals announced that the European Commission has granted approval for the ...
BRIUMVI Receives Green Light from European Commission as Treatment for Relapsing Multiple Sclerosis
The European Commission (EC) gave the green light for the use of TG Therapeutics‘ BRIUMVI (ublituximab-xiiy) to treat relapsing forms ...
