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Urigen Pharmaceuticals, Inc.

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Latest From Urigen Pharmaceuticals, Inc.

US FDA Panel To Weigh Safety, Tolerability Issues For One New, Two Approved Cancer Drugs

Oncologic Drugs Advisory Committee will review Spectrum’s poziotinib for use in targeted subset of patients with previously treated non-small cell lung cancer; ODAC also will consider next steps for two approved drugs with adverse survival trends in postmarketing studies: Oncopeptides’ Pepaxto in multiple myeloma and Secura Bio’s Copiktra for CLL/SLL.

Advisory Committees Post Market Regulation & Studies

BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.

Europe Approvals

Gilead’s Lenacapavir, Takeda’s Maribavir Due For Oral Explanations At EMA

The sponsors of four drugs were due or possibly due to appear before the European Medicines Agency to explain why their respective products merit EU-wide approval.  

Europe Approvals

Partnerships Picks For GeNeuro’s MS Antibody

The Geneva-based biotech has been developing its antibody temelimab for the last 16 years. Data from its Phase II studies show its need for a big pharma development partner.

New Science Research & Development
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