Will AI revolutionize drug development? Researchers explain why it depends on how it’s used
Researchers have applied AI to every step of the drug development process. But this might not be enough to design safe and ...
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FDA grants pre-market approval to HLB Life Science’s disposable syringe
The US Food and Drug Administration (FDA) has granted pre-market approval (510K) to HLB Life Science’s Sofject disposable ...
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FDA Sued Over Laboratory Developed Tests Final Rule
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...
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FDA Takes a Big Step Forward with the Electronic Submission Gateway
Security is strengthened by reducing the attack surface, but this also makes the submission process far more user-friendly.
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Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics
In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, ...
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How Process Development Enhances Drug Discovery Outcomes
Robust process development is essential in pharmaceutical manufacturing, optimizing drug discovery and ensuring regulatory ...
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CAPR Stock Up on Completion of Rolling Submission of DMD Drug BLA
Shares of Capricor Therapeutics CAPR gained 8.4% on Thursday following the completion of the submission of a biologics ...
FDA proposes new tests to detect asbestos in cosmetics and other products containing talc
The proposed rule is required under a law passed by Congress last year, and is intended to ensure the safety of makeup and ...
FDA says decongestant in many cold medicines doesn't work. So what does?
Changes are coming to the cold and cough aisle of your local pharmacy: U.S. officials are moving to phase out the leading ...
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FDA: ‘Active’ Ingredient in Cold Medicine Doesn’t Work
An FDA panel’s decision that phenylephrine is not an effective decongestant applies only to oral medications. The drug is ...
Biotech Stocks Facing FDA Decision In January 2025
As we enter the new year, all eyes are on the biotech companies awaiting key FDA decisions in January. In 2024, the FDA approved 50 ...
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FDA says decongestant in many cold medicines doesn’t work. So what does?
Last month the Food and Drug Administration formally proposed revoking its use in pills and liquid solutions, kicking off a process that’s likely to force drugmakers to remove or reformulate ...