Regulatory Affairs

Regulatory Affairs

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.
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.
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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.
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Midatech secures manufacturing certification from Spanish regulatory authority
Midatech Pharma has received manufacturing certification from Spanish regulatory authority AEMPS.
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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%.
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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).
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Samsung Bioepis’ trastuzumab biosimilar gets EC approval for breast cancer
By PBR Staff Writer
The European Commission (EC) has approved Samsung Bioepis' Ontruzant, a biosimilar version of Genentech’s Herceptin (trastuzumab), for the treatment of breast cancer in early and metastatic stages and also for metastatic gastric cancer.
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Roche’s Hemlibra secures FDA approval for hemophilia A with inhibitors
By PBR Staff Writer
Roche’s Hemlibra (emicizumab-kxwh) has been approved by the US Food and Drug Administration (FDA) for routine prophylaxis to prevent or reduce frequency of bleeding episodes in patients with hemophilia A who have factor VIII inhibitors.
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