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16-30 of 3554 results
Teva loses Copaxone patent dispute case to Mylan in UK
By PBR Staff Writer
The UK High Court of Justice has given a decision in favor of Mylan and Synthon over their dispute concerning the patent of Teva Phamaceutical Industries’ multiple sclerosis (MS) treatment Copaxone which was ruled to be invalid due to obviousness.
Regulatory Affairs > News
FDA rejects PTC Therapeutics' application for Duchenne drug
By PBR Staff Writer
PTC Therapeutics has failed to secure the approval from the US Food and Drug Administration (FDA) for its experimental drug Ataluren (Translarna) to treat nonsense mutation Duchenne muscular dystrophy (nmDMD).
Regulatory Affairs > News
Synlogic gets orphan drug status for SYNB1618 to treat phenylketonuri
Synlogic has secured orphan drug status from the US Food and Drug Administration (FDA) for o SYNB1618 preclinical-stage drug candidate for the treatment of phenylketonuria (PKU).
Regulatory Affairs > News
Novartis’ cancer combo Tafinlar and Mekinist gets FDA breakthrough status
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation after complete resection.
Regulatory Affairs > News
Janssen gets two US FDA approvals for Simponi Aria to treat active psoriatic arthritis
Janssen Biotech announced that the US Food and Drug Administration (FDA) has approved Simponi Aria (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
Regulatory Affairs > News
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.
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
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
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.
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
16-30 of 3554 results