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Regulatory Affairs

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.
Regulatory Affairs > News
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.
Regulatory Affairs > News 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
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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).
Regulatory Affairs > News
Do you have a robust and compliant CAPA System?
| By NSF Health Sciences Pharma Biotech PBR
Pharma biotech companies around the globe are struggling to juggle numerous priorities and challenges. One of their biggest struggles is to effectively manage CAPAs.
Regulatory Affairs > White Papers
How to write to Regulatory Agencies when things go wrong
| By NSF Health Sciences Pharma Biotech PBR
Your essential guidance on what to do next after you receive a less than positive regulator's audit report.
Regulatory Affairs > White Papers
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
Pharma Integrates 2017 – Meet NSF, 15-16 November, London, UK
After the success of the 2016 conference, NSF International are pleased to be exhibiting again at Pharma Integrates 2017.
Regulatory Affairs > Press Releases
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
NSF’S New Highly Interactive Pharmaceutical Training Workshops for 2017/2018
We have listened to you and taken your feedback on board to create our new pharmaceutical training workshops for 2017/2018.
Regulatory Affairs > Press Releases
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.
Regulatory Affairs > News
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.
Regulatory Affairs > News
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
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