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Drug 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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