FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The Food and Drug Administration approved the pill from Vertex Pharmaceuticals for acute pain that often occurs after surgery ...
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FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
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Karolinska Development’s portfolio company Dilafor advances tafoxiparin following successful meetings with FDA and European regulatory authorities
FDA, and European Health Agencies, regarding the continued development of the company’s drug candidate tafoxiparin. The completed meetings mark the end of a comprehensive dialogue with ...
As Trump and RFK Jr. move to upend drug making, Seattle biotech bets on science
Robert F. Kennedy Jr. may soon be America's top pharmaceutical regulator. That is cause for concern in Seattle’s biotech ...
PharmaTimes4d
Cartesian Therapeutics announces FDA agreement for new trial
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...
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The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
Protheragen Introduces One-Stop Therapeutic Development Solutions to Accelerate Ophthalmic Drug Research
Protheragen launches a full spectrum of ophthalmic drug preclinical R&D services to streamline the complex process of developing effective therapies for eye diseases. Protheragen, a reputable research ...