Regulatory Affairs

Regulatory Affairs News

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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.
Regulatory Affairs > News
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).
Regulatory Affairs > News
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.
Regulatory Affairs > News
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.
Regulatory Affairs > News
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).
Regulatory Affairs > News
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.
Regulatory Affairs > News
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.
Regulatory Affairs > News
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.
Regulatory Affairs > News
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.
Regulatory Affairs > News
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).
Regulatory Affairs > News
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).
Regulatory Affairs > News
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
Midatech secures manufacturing certification from Spanish regulatory authority
Midatech Pharma has received manufacturing certification from Spanish regulatory authority AEMPS.
Regulatory Affairs > News
UK regulator accuses Concordia of overcharging NHS for thyroid drug
By PBR Staff Writer
The UK Competition and Markets Authority (CMA) has accused Canadian pharma company Concordia International of abusing its dominant position by increasing the price of a thyroid drug by about 6,000%.
Regulatory Affairs > News
Novartis gets EC approval for Tasigna to treat Ph+ CML-CP in children
By PBR Staff Writer
Novartis has secured approval from the European Commission (EC) for its Tasigna (nilotinib) to treat pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Regulatory Affairs > News
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