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US FDA Flags 8 Observations at Sun Pharma’s Halol Facility After GMP Inspection
In a filing made public on Saturday, the company said the inspection concluded with the U.S. regulator issuing Form 483, ...
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Syngene's Bengaluru-based facility gets 'NAi' status from US FDA
The inspection concluded successfully, with the facility found to be in compliance with the required regulations.
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NATCO Pharma's Hyderabad-based plant gets 'one' Form 483 observation post US FDA audit
On conclusion of the inspection, the company received one observation in the Form-483. The company believes that the observation is procedural in nature. The company is confident to address this ...
Capricor: A Hold Rating With Regulatory FDA Form Given For Deramiocel Advancement
Capricor Therapeutics' rating was downgraded amid FDA inspection risks, regulatory uncertainty, and potential delays in ...
Quality Assurance & Food Safety4d
FDA Educational Materials Outline New Dietary Ingredient Notification Process for Supplements
The two videos and a supplemental fact sheet are intended to help dietary supplement manufacturers and distributors correctly ...
FDA plans to use AI to speed up drug and food safety reviews
The U.S. Food and Drug Administration (FDA) says it plans to use artificial intelligence (AI) to help speed the approval of ...
Capricor falls after facility inspection related to deramiocel
Capricor Therapeutics shares dropped after the U.S. FDA inspected its San Diego manufacturing facility. Read more here.
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Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program
U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensure Advisory Committee meeting scheduled for July 30, 2025 Mid-cycle ...