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Praxis Relutrigine NDA Accepted for Rare Pediatric Epilepsies

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

FDA OKs Higher Dose Regimen for Spinraza

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

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

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Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered bad cholesterol compared wi...

FDA Grants Accelerated Approval to Rockets Gene Therapy

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

FDA Flags Manufacturing/Labeling Violations at STAQ Pharma Ohio Facility

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FDA sends an untitled letter to STAQ Pharma of Ohio, citing significant manufacturing, quality control, and labeling violations.

Editorial Criticizes Makary Over Leadership Decisions

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

Medtronic Wins Expanded Clearance for AXiS System

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

FDA Guide on Patient Preferences in Device Submissions

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FDA releases a final guidance titled Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycl...

FDA Flags Recall of Erbe Flexible Cryoprobes Over Rupture Hazard

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Erbe USA recalls its flexible cryoprobes due to their potential to rupture during activation, which could result in severe injury ...

Wave Life Sciences Reports Mixed Data on Obesity Therapy

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Wave Life Sciences reports new interim Phase 1 data Thursday indicating that a 240 mg dose of its investigational obesity therapy ...