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Accelerated Rare Disease Cures Program Strategic Plan Out

[ Price : $8.95]

The CDER Accelerated Rare disease Cures Program issues a strategic plan for 2025-2030 with goals and strategic objectives for each...

AstraZeneca Reports Positive Data on COPD Biologic

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AstraZeneca reports data from the Phase 3 OBERON and TITANIA trials showing that tozorakimab is the first biologic to demonstrate ...

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...

Bayer Gets OK for Lung Cancer Drug

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FDA grants Bayer an accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for certain adult patients with locally adv...

FDA Still Reviewing Rezolute Phase 3 Info

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Rezolute says FDA is still reviewing the additional data the agency requested from the companys Phase 3 sunRIZE trial of ersodetug...

Nanoscope BLA Accepted for Vision Restoration Gene Therapy

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FDA accepts for review a Nanoscope Therapeutics BLA seeking approval for Mogenry, an optogenetic gene therapy designed for vision ...

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.