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FDA Lays Out Next Phase of Plan to Reduce Animal Testing

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FDA outlines expanded efforts to reduce animal testing in drug development after reporting significant first-year progress under i...

Trump Signs Executive Order to Accelerate Psychedelic Therapies

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President Trump signs an executive order aimed at accelerating the development and availability of psychedelic-based treatments fo...

Padcev-Keytruda Combo for Broader Bladder Cancer

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FDA accepts for priority review a Pfizer and Astellas Pharma supplemental BLA for Padcev (enfortumab vedotin-ejfv) that seeks to ...

FDA Updates Guide on Expanded Access to Investigational Drugs

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FDA updates a guidance clarifying how patients, physicians, and drug developers can access investigational therapies outside of cl...

Nektar Reports Favorable Data in Alopecia Areata Study

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Nektar Therapeutics reports new 52-week data from its mid-stage REZOLVE-AA trial, showing continued improvement in hair regrowth a...

FDA Sets Higher Approval Bar for Passage Bio Dementia Therapy

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FDA tells Passage Bio that a randomized controlled trial will be required to support approval of its experimental gene therapy for...

Philips Wins Clearance for AI-powered Spectral CT System

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FDA clears a Philips 510(k) for its new Spectral CT Verida system, which the company describes as the first AI-powered detector-ba...

Guidance on Impurity Standards For Fermentation-Based Antibiotics

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FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentat...

FDA Streamlined Compliance Policy for Certain Respirators

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FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators ...

Opna Bio Wins FDA Fast Track for Multiple Myeloma Drug

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FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with r...