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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.
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FDA Opens Public Consultation on AI Medical Devices
The FDA is seeking public input on regulating generative AI in medical devices. Learn how new oversight could impact healthcare innovation and patient safety.