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Hogan Lovells Hires Former FDA Chief Counsel Raza

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Former FDA chief counsel Mark Raza joins Hogan Lovells Cadwalader as senior counsel in its Pharmaceuticals and Biotechnology pract...

Breakthrough Therapy Designation for UCBs Cimzia

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FDA grants breakthrough therapy designation for UCBs Cimzia in some pregnant women with antiphospholipid syndrome.

FDA Eases Compounding for Neonatal Parenteral Nutrition Drugs

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FDA issues a guidance entitled Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates ...

Bioresearch Monitoring Violations Found

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FDA warns Stephen Fallon of Wilton Manors, FL, about bioresearch violations in his role as clinical investigator of a trial of an ...

Repeat Fenwal International CGMP Issues Cited

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FDA cautions Fenwal International about CGMP deviations at its Maricao, Puerto Rico, facility that manufactures blood pack units.

FDA Planning Pregnancy Exposure Registry Study

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FDA solicits public comment on a proposed study to learn from healthcare providers their understanding of barriers to higher patie...

Traveres Filspari Promotion Overstates Kidney Benefits: FDA

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FDA cites Travere Therapeutics over promotional materials for Filspari (sparsentan) because they contain misleading claims about t...

Intellia BLA Gets Priority Review for Hereditary Angioedema

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FDA accepts for priority review an Intellia Therapeutics BLA for lonvo-z, an in vivo CRISPR-based therapy for treating hereditary ...

Krazatis Accelerated Approval for Colorectal Cancer Withdrawn

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FDA acknowledges that Bristol Myers Squibbs accelerated approval of Krazati (adagrasib) in combination with cetuximab for adults w...

FDA Acting Center Directors Made Permanent

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HHS names CDER acting director Michael Davis and CBER acting director Karim Mikhail as permanent directors of their respective off...