Regulatory Affairs

Regulatory Affairs News

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Seattle Genetics’ Adcetris gets FDA priority review for Hodgkin lymphoma
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review to a Seattle Genetics’ supplemental biologics license application (BLA) that seeks approval of (brentuximab vedotin) in combination with chemotherapy in combination with chemotherapy for the frontline treatment of advanced classical Hodgkin lymphoma.
Regulatory Affairs > News
Mylan launches Estrace Cream generic after FDA approval
Mylan has launched Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace Cream, in the US.
Regulatory Affairs > News
Roche secures cancer drug approvals in Europe and US
By PBR Staff Writer
Switzerland-based drug manufacturer Roche has secured approvals for two cancer drugs in Europe and the US.
Regulatory Affairs > News
Spark’s gene therapy Luxturna secures FDA approval for rare form of blindness
By PBR Staff Writer
Spark Therapeutics’ gene therapy Luxturna (voretigene neparvovec) has been approved by the US Food and Drug Administration (FDA) for the treatment of children and adults having a rare inherited form of vision loss that could lead to blindness.
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Alnylam, Sanofi submit MAA to EMA for patisiran to treat hereditary ATTR amyloidosis
Alnylam Pharmaceuticals and Sanofi Genzyme have submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for patisiran, an investigational RNAi therapeutic targeting transthyretin (TTR) for the treatment of adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
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FDA proposes risk-based enforcement approach to homeopathic drugs
By PBR Staff Writer
The US Food and Drug Administration (FDA) is proposing new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.
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Aclaris gets FDA nod for Eskata drug to treat raised seborrheic keratoses
Aclaris Therapeutics has secured approval from the US Food and Drug Administration (FDA) for Eskata (hydrogen peroxide) topical solution, 40% (w/w) for the treatment of raised seborrheic keratoses or SKs.
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Shire gets EC nod for lyophilized Oncaspar to treat acute lymphoblastic leukemia
By PBR Staff Writer
Shire has secured marketing approval from the European Commission (EC) for new formulation of Oncaspar to treat patients with acute lymphoblastic leukemia (ALL).
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Sanofi’s Admelog (insulin lispro injection) gets FDA approval to treat diabetes
By PBR Staff Writer
Sanofi’s Admelog (insulin lispro injection) has been approved by the US Food and Drug Administration (FDA) to help diabetic patients control their blood sugar levels at mealtime.
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NICE says lenvatinib should be available on NHS
The National Institute for Health and Care Excellence (NICE) has announced that lenvatinib should be available on the National Health Service (NHS) to give people with advanced kidney cancer a new treatment option.
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Novo Nordisk’s Ozempic diabetic drug secures FDA approval
By PBR Staff Writer
Novo Nordisk’s Ozempic (semaglutide injection) has been approved by the US Food and Drug Administration (FDA) to enhance glycaemic control in adults with type 2 diabetes mellitus.
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Amgen’s Repatha approved by FDA for heart attack and stroke prevention
By PBR Staff Writer
Amgen’s cholesterol drug Repatha (evolocumab) has been approved by the US Food and Drug Administration (FDA) to prevent heart attacks, strokes and coronary revascularizations in adults having cardiovascular disease.
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Indivior's Sublocade secures FDA approval to treat opioid use disorder
By PBR Staff Writer
Indivior’s Sublocade (buprenorphine extended- release) injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate to severe opioid use disorder (OUD).
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AstraZeneca submits sNDA for Tagrisso to treat EGFRm NSCLC
By PBR Staff Writer
AstraZeneca has submitted a supplemental new drug application (sNDA) to Japan’s pharmaceuticals and medical devices agency seeking approval for Tagrisso (osimertinib) as a first line treatment for patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).
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European Commission approves Tremfya to treat moderate to severe plaque psoriasis
Janssen-Cilag International announced that the European Commission (EC) has approved Tremfya (guselkumab) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Regulatory Affairs > News
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