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Product Reviews & Approvals

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Approvals

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FDA's NDA And BLA Approvals: Cotempla XR-ODT, Baxdela, Mydayis, Rituxan Hycela, Haegarda

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Key Indian Panel Go-Ahead For Novartis’ Kisqali

Just months after the US FDA cleared Kisqali, Novartis appears on course to bring the breast cancer therapy to India after a key local expert panel recommended the product for marketing in the country, though the filing route through a local Sandoz company has raised some questions.

India Approvals

Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

Approvals Biosimilars

HIV At US FDA: Gilead's Novel Agent, Viiv's Two-Drug Maintenance Regimen Filed

The latest HIV drug development news and highlights from our FDA Performance Tracker.

Performance Tracker Approvals

FDA's NDA And BLA Approvals: Symjepi, Calcium Gluconate

Original new drugs and biologics recently approved by US FDA.

Approvals Regulation

Multiple Sclerosis Subtype 'Relatedness' Drove Debate On Ocrevus Approval

Genentech's Ocrevus BLA set off internal US FDA dispute about relationship between different subgroups of disease: Can strong evidence in one form (relapsing MS) confirm a weak study in another (primary progressive MS)? Our Drug Review Profile looks at how FDA rationalized approval of Ocrevus for PPMS.

Drug Review Profile Drug Approval Standards
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Drug Reviews

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Latest From Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Majority Of British Public And GPs Don’t Trust Drug Industry, UK Review Confirms

The Association of the British Pharmaceutical Industry is to discuss the recommendations from a report requested by the Chief Medical Officer for England that has found that most UK adults and general practitioners do not trust pharma.

Drug Review United Kingdom

Pfizer’s EPO Biosimilar Stalls In US On Hospira Compliance Woes

US FDA hands Pfizer its second complete response letter for its proposed biosimilar to Epogen/Procrit, citing manufacturing compliance concerns at a legacy Hospira manufacturing facility in Kansas that was the target of a February warning letter. Issue “is not directly related to EPO itself,” Pfizer’s Salomon Azoulay says.

Biosimilars Complete Response Letters

Biomarkers: FDA/Industry Group Shaping 'Points-To-Consider' On Assay Validation

Critical Path Institute will deliver white paper on key step in biomarker qualification process: concepts to consider in validating assays to measure the biomarker’s performance. White paper has US FDA input, and will in turn help inform agency guidance and internal processes.

Clinical Trials Drug Approval Standards

Novo’s Victoza CV Benefit Claim Could Be Narrowed With FDA Panel Vote

US advisory committee strongly endorses cardiovascular risk reduction claim for the GLP-1 agonist but some panelists say new indication should be limited to diabetics with established CV disease, not the broad primary prevention claim Novo Nordisk is seeking.

Advisory Committees Drug Review

Imminent EU CHMP Opinions: Kidney And Breast Cancer, Mastocytosis, MS, Emphysema & Hepatitis C

Among products that are due for a go/no-go recommendation by the European Medicines Agency this week are new drugs for conditions such as cancer, multiple sclerosis, mastocytosis, HIV and hepatitis C.

Drug Review Europe
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