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FDA Faces Pressure to Review China Gene Therapy Oversight
Lawmakers are pressuring the FDA to tighten oversight of international gene therapy trials following three patient deaths linked to overseas research.
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Aurobindo Pharma Unit Cleared After US FDA Inspection
Aurobindo Pharma’s Auropeptides facility receives a single observation following a US FDA inspection. Learn about the impact on regulatory compliance.
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New Stem Cell Donor Options Boost Blood Cancer Survival
New research shows haploidentical stem cell transplants now offer survival rates comparable to perfect matches, expanding donor access for blood cancer.
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US FDA Issues 4 Observations to Natco Pharma Facility
Natco Pharma has received four US FDA observations following a facility inspection in Visakhapatnam. The company is actively addressing the findings.
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Aurobindo Pharma Receives US FDA Inspection at Auropeptides
Aurobindo Pharma confirms a recent US FDA inspection at its Auropeptides facility. Learn the details of the audit and what it means for API manufacturing.
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Adaptin Bio Launches Phase I Trial for Glioblastoma Drug
Adaptin Bio has opened enrollment for a Phase I trial testing a new glioblastoma therapy. Learn about the trial's goals for treating brain cancer.
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India Seeks Medical Device Industry Input for Regulations
India’s Department of Pharmaceuticals is seeking industry input to modernize medical device regulations, aiming to boost local manufacturing and innovation.
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FDA Approves PrecivityAD2 Blood Test for Early Alzheimer’s
FDA clears the PrecivityAD2 blood test for adults 40+ to detect Alzheimer’s biomarkers, streamlining early diagnosis and access to clinical care.
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Akeso’s B7-H3 ADC Cleared for Phase I Solid Tumor Trials
Akeso gains regulatory clearance for Phase I trials of its B7-H3 targeted ADC, AK157D1, aiming to transform treatment outcomes for advanced solid tumors.
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FDA Approves RefluxStop: New Breakthrough for GERD Care
The FDA has approved the RefluxStop implant for GERD, offering a new, anatomically restorative surgical option to manage chronic acid reflux symptoms.