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Human Drugs

Group Backs Circulating Tumor DNA as Early Endpoint

Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early endpoint in clinical t...

R3 Selling Unapproved Drugs, Biologics, FDA Says

FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that are unlicensed biol...

Biologics

HHS Seeks Input on Categories of Federal Vaccine Recommendations

HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enou...

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Biologics

FDA 3-Month Review Extension on Capricor Gene Therapy

FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy ...

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Human Drugs

Study Finds Severe Liver Injury in Small Number of Avacopan Patients

As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme elevations were unco...

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Biologics

Clinical Hold on Regenxbio Hunter Syndrome Gene Therapy

FDA places a clinical hold on Regenxbio's investigational gene therapy RGX-121 after asymptomatic spine MRI findings were identified in five participa...

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Medical Devices

Early Alert on CooperSurgical Neonatal CPAP Ventilator

FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive ai...

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Medical Devices

Roche/Lilly Alzheimers Test Cleared

FDA clears Roche/Eli Lillys Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test as a single blood-based option to aid in identifying amyloid pathol...

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Human Drugs

Scholar Rock Removes Catalent Facility from BLA to Advance Apitegromab

Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treatment for spinal muscular atrophy.

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Human Drugs

Lawmakers Urge FDA to Up Scrutiny of Clinical Data From China

House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging FDA intensify safeguards on clinical trial data ge...