Regulatory Affairs

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FDA approves GSK’s Shingrix to prevent shingles in adults aged 50 and over
By PBR Staff Writer
GlaxoSmithKline’s (GSK) Shingrix (Zoster Vaccine Recombinant, Adjuvanted) vaccine has been approved by the US Food and Drug Administration (FDA) for the prevention of herpes zoster (shingles) in adults aged 50 years and over.
Regulatory Affairs > News
FDA approves Kite’s Car T therapy Yescarta for B-Cell Lymphoma
By PBR Staff Writer
Kite Pharma’s chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) has been approved by the US Food and Drug Administration for the treatment of relapsed or refractory large B-cell lymphoma in adult patients who had at least two lines of systemic therapy.
Regulatory Affairs > News
US FDA accepts sBLA for Imfinzi in locally advanced and unresectable NSCLC
AstraZeneca and MedImmune announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
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US FDA accepts BMS’ application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma
Bristol-Myers Squibb (BMS) announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
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US federal judge invalidates Allergan patents on Restasis
By PBR Staff Writer
A US federal judge has ruled four of Allergan’s patents over its dry eye medicine Restasis (Cyclosporine Ophthalmic Emulsion) 0.05% to be invalid for covering obvious ideas.
Regulatory Affairs > News
Janssen submits NDA to FDA for apalutamide to treat non-metastatic castration-resistant prostate cancer
Janssen Biotech has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC).
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Synthon gets regulatory approval for glatiramer acetate 40 mg/ml in Europe
Synthon has concluded the decentralized procedures for glatiramer acetate 40 mg/ml pre-filled syringe for the treatment of relapsing forms of multiple sclerosis and received regulatory approval in Europe.
Regulatory Affairs > News
Seattle Genetics gets FDA breakthrough therapy status for Hodgkin lymphoma treatment Adcetris
By PBR Staff Writer
Seattle Genetics has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma.
Regulatory Affairs > News
Merck, Pfizer get EC approval for skin cancer drug Bavencio
By PBR Staff Writer
Merck and Pfizer have secured the approval of their skin cancer drug Bavencio (avelumab) from the European Commission (EC) as a monotherapy for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults.
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Roche gets EC nod for Gazyvaro to treat advanced follicular lymphoma
By PBR Staff Writer
Roche has secured approval from the European Commission (EC) for its Gazyvaro (obinutuzumab) in combination with chemotherapy for the treatment for previously untreated advanced follicular lymphoma.
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Novartis’ Rydapt approved in Europe for AML and rare blood disorders
By PBR Staff Writer
Novartis’ cancer drug Rydapt (midostaurin) has been approved by the European Commission (EC) for a mutated form of acute myeloid leukemia (AML) and certain rare blood disorders.
Regulatory Affairs > News
Pfizer announces outcome of FDA's ODAC meeting for SUTENT in patients at high risk of recurrent renal cell carcinoma after surgery
Pfizer announced that the US Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical removal of the cancer-containing kidney).
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Ipsen gets EC approval for Xermelo to treat carcinoid syndrome diarrhea
Ipsen announced that the European Commission (EC) has approved Xermelo (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.
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GSK, Innoviva get FDA nod for COPD treatment Trelegy Ellipta
By PBR Staff Writer
GlaxoSmithKline (GSK) and Innoviva have secured approval from the US Food and Drug Administration (FDA) for once-daily and single inhaler triple therapy, Trelegy Ellipta, to treat patients with chronic obstructive pulmonary disease (COPD).
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FDA grants orphan drug status for Motif Bio’s Staphylococcus Aureus lung treatment
The US Food and Drug Administration (FDA) has granted Motif Bio's investigational drug candidate, iclaprim, orphan drug designation to treat of Staphylococcus aureus lung infections in patients with cystic fibrosis.
Regulatory Affairs > News
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