FDA Drug Development Process

New Pain Drug Gets FDA Nod

FDA Approves First New Non-Opiod Painkiller in Decades

Journavx is designed to eliminate the risks of addiction and overdose associated with medications like Vicodin and OxyContin.

U.S. News & World Report · 1d

FDA Approves New Painkiller That Shows Promise and Challenges of Opioid Alternatives

U.S. officials have approved a new type of pain drug designed to eliminate the risks of addiction and overdose associated with opioids

Bloomberg on MSN · 1d

New Pain Drug Gets FDA Nod as Safer Alternative to Addictive Opioids

Vertex Pharmaceuticals Inc. gained US approval for the first new type of painkiller in more than two decades, paving the way for a safer alternative to addictive opioids that have been linked to hundreds of thousands of deaths.

JD Supra2d

FDA Publishes Its First Draft Guidance On Use of Artificial Intelligence in the Development of Drugs and Biological Products

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug

Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...

technologynetworks12d

Exploring the Frontiers of Pharmaceutical Innovation

Each regulatory body, such as the FDA in the US or the EMA in Europe ... phase-appropriate quality system is one of the greatest hurdles in the drug development process. AI and machine ...

Texas Public Radio3d

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 ...

PharmaTimes3d

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 ...

SiliconRepublic11d

CergenX making Waves with new FDA designation

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...

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