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Human Drugs

FDA Warns of Serious Liver Risks Linked to Tavneos

FDA issues a safety alert warning that patients taking Amgens Tavneos (avacopan) for a rare autoimmune condition may face a risk of severe liver injur...

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FDA General

FDA Seeking Input on Expanding Digital Health Tech in Trials

Looking to modernize drug and biologic development, FDA seeks industry and public input on how to expand the use of digital health technologies in cli...

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FDA General

Scholar Rock Refiles BLA for Spinal Muscular Atrophy Therapy

Scholar Rock resubmits its BLA for apitegromab, an investigational therapy for children and adults with Spinal Muscular Atrophy.

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Biologics

Novel CAR-T Therapy Gets Breakthrough Status

A novel off-the-shelf CAR-T cell therapy developed by researchers at Washington University School of Medicine in St. Louis receives an FDA breakthroug...

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Human Drugs

FDA Pharma Disclosures Raise Transparency-Confidentiality Tensions

FDA's more aggressive approach to publicizing its criticisms of drugmakers draws both praise from investors and concern across the pharmaceutical indu...

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Human Drugs

FDA Records Reveal Lapses in Drug Safety Checks: Analysis

FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality checks.

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Biologics

FDA Crackdown on CAR-T Promotion in Coordinated Action

In a coordinated action, CBER issues four untitled letters targeting promotional materials for leading T-cell therapies and signaling heightened scrut...

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Human Drugs

Praxis Relutrigine NDA Accepted for Rare Pediatric Epilepsies

FDA accepts for priority review a Praxis Precision Medicines NDA for relutrigine, an investigational therapy targeting rare genetic epilepsies.

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Human Drugs

FDA OKs Higher Dose Regimen for Spinraza

FDA approves a higher-dose regimen of Biogens Spinraza (nusinersen) for treating spinal muscular atrophy.

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Human Drugs

Mercks Oral PCSK9 Candidate Cuts LDL Cholesterol in Late-Stage Trial

Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered bad cholesterol compared with commonly used non...