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Regulatory Affairs

FDA approves Pharmacyclics and Janssen' Imbruvica to treat Waldenstrom's macroglobulinemia By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Imbruvica (ibrutinib) capsules as the first therapy indicated specifically to treat patients with Waldenström's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma.
Regulatory Affairs > News
Bristol-Myers' Evotaz gets FDA approval for HIV-1 treatment in adults By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's Evotaz tablets in combination with other antiretroviral agents to treat HIV-1 infection in adults.
Regulatory Affairs > News Vifor Pharma hyperphosphatemia drug Velphoro gets Swissmedic approval By PBR Staff Writer
Vifor Pharma has received approval from the Swiss agency for Therapeutic Products (Swissmedic) for Velphoro, a non-calcium, iron-based, chewable phosphate binder, for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis.
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EMA committee issues positive opinion for Merck's Sivextro to treat ABSSSI
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for Merck's investigational antibiotic Sivextro (tedizolid phosphate) to treat acute bacterial skin and skin structure infections (ABSSSI) in adults.
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FDA approves Symplmed's hypertension drug Prestalia
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Symplmed Pharmaceuticals' Prestalia tablets, licensed from Servier (Suresnes, France), to treat hypertension.
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EMA recommends sale suspension of medicines based on GVK Bio’s ‘flawed’ clinical data
By PBR Staff Writer
The European Medicines Agency has recommended suspension of sale of around 700 medicines whose authorization was given based on clinical trial conducted by Hyderabad, India based GVK Biosciences.
Regulatory Affairs > News
BioCryst gets FDA fast track status for BCX4161 to treat Hereditary Angioedema
BioCryst Pharmaceuticals, announced that the U.S. Food and Drug Administration has granted Fast Track designation for BCX4161, a novel, orally administered, selective inhibitor of plasma kallikrein in advanced clinical development for the treatment of hereditary angioedema.
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Genzyme's Cerdelga gets European marketing authorization for Gaucher Disease
By PBR Staff Writer
The European Commission (EC) has granted marketing authorization for Genzyme's Cerdelga (eliglustat) capsules, a first line oral therapy for certain adults living with Gaucher disease type 1.
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FDA approves Novartis' Cosentyx to treat plaque psoriasis
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Swiss drug-maker Novartis' Cosentyx (secukinumab) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
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European label update of Bayer’s Xarelto now including guidance for use in AF patients undergoing cardioversion
Bayer HealthCare announced the inclusion of specific guidance for doctors treating patients with non-valvular atrial fibrillation (AF) undergoing cardioversion to the European Xarelto (rivaroxaban) Product Information.
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Verastem gets European orphan medicinal product status for VS-5584 in mesothelioma
By PBR Staff Writer
The European Commission has granted orphan medicinal product designation for Verastem's VS-5584, a dual mTORC1/2 and PI3K inhibitor, designed to treat patients with mesothelioma.
Regulatory Affairs > News
FDA approves Baxter's Phoxillum Renal Replacement Solution
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Baxter International's Phoxillum Renal Replacement Solutions (BK4/2.5 and B22K4/0) for use during continuous renal replacement therapy (CRRT).
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