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Regulatory Affairs

European Commission approves new indication for Novartis’ Lucentis eye drug By PBR Staff Writer
The European Commission has approved the sixth indication for Novartis’ Lucentis, making it the only treatment available for a range of choroidal neovascularization (CNV) conditions.
Regulatory Affairs > News
UK's CMA fines Pfizer and Flynn Pharma for epilepsy drug price hike By PBR Staff Writer
Pfizer and Flynn Pharma have been fined a record amount for abusing their dominant position in the UK by charging excessive and unfair prices for an anti-epilepsy drug.
Regulatory Affairs > News Amgen and Allergan submit bevacizumab biosimilar application to EMA Amgen and Allergan have submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab).
Regulatory Affairs > News
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GSK seeks EU approval for inhaled triple combo COPD therapy
By PBR Staff Writer
GlaxoSmithKline (GSK) is seeking approval in Europe for once-daily closed triple combination therapy to treat chronic obstructive pulmonary disease (COPD) patients.
Regulatory Affairs > News
FDA approves cardiovascular indication for Jardiance
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a new indication for Jardiance (empagliflozin), a type 2 diabetes treatment from Boehringer Ingelheim and Eli Lilly.
Regulatory Affairs > News
Bristol-Myers Squibb’s Opdivo approved for Hodgkin lymphoma in Europe
By PBR Staff Writer
Bristol-Myers Squibb has secured approval from the European Commission for Opdivo (nivolumab) to treat adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
Regulatory Affairs > News
Teva’s Trisenox approved in Europe for first line treatment of APL
By PBR Staff Writer
The European Commission has expanded the scope of Teva Pharmaceutical Industries’ Trisenox, approving its use to treat patients with newly diagnosed acute promyelocytic leukaemia (APL).
Regulatory Affairs > News
FDA extends indication for GSK’s FluLaval Quadrivalent influenza vaccine in infants
By PBR Staff Writer
GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) to expand FluLaval Quadrivalent (influenza vaccine) indication.
Regulatory Affairs > News
Amgen’s Parsabiv approved in Europe for sHPT treatment in adults with CKD
By PBR Staff Writer
Amgen has secured approval from the European Commission (EC) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Regulatory Affairs > News
Pfizer secures EU approval for Ibrance breast cancer drug
By PBR Staff Writer
Pfizer has secured approval from the European Commission (EC) for Ibrance (palbociclib) to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer.
Regulatory Affairs > News
FDA approves Gilead’s Vemlidy to treat chronic hepatitis B virus infection
The US Food and Drug Administration (FDA) has approved Gilead Sciences' Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
Regulatory Affairs > News
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Regulatory Affairs > Press Releases
FDA approves Amgen’s Enbrel to treat children with plaque psoriasis
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for the expanded use of Enbrel (etanercept) to treat children with chronic moderate-to-severe plaque psoriasis.
Regulatory Affairs > News
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