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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

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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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...

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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

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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FDA General

Editorial Criticizes Makary Over Leadership Decisions

The Washington Times publishes an opinion piece that draws attention to growing criticism of FDA commissioner Marty Makary.

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Medical Devices

Medtronic Wins Expanded Clearance for AXiS System

Medtronic wins 510(k) clearance for its Stealth AXiS surgical system in cranial and ear, nose and throat procedures.

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Biologics

FDA Grants Accelerated Approval to Rockets Gene Therapy

FDA gives Rocket Pharmaceuticals an accelerated approval for its gene therapy Kresladi (marnetegragene autotemcel) for children with severe Leukocyte ...