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Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...
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Investor's Business Daily on MSNCapricor Therapeutics Hammered On A Surprise FDA RejectionShares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental ...
The Food and Drug Administration has approved a first of its kind, once-yearly shot designed to protect dogs from fleas and ...
The Ozark Trail 64-ounce water bottle sold at Walmart can eject its lid with dangerous force. This design flaw has caused ...
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.
A major infant ventilator component has been recalled because it could come apart during use, potentially causing organ ...
The company said it was optimistic that the issues identified by the Food and Drug Administration could be resolved with new data.
Lawmakers are making slow headway on assembling a fiscal year 2026 package of 12 annual funding bills that provide money for ...
In a recent panel conversation, healthcare and industry experts discussed where to find reliable guidance in a sea of ...
The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...
The Food and Drug Administration (FDA) has accepted for review Milestone’s response to issues raised in a Complete Response Letter (CRL) for etripamil nasal spray (Cardamyst ™ ), an investigational ...
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