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Makary Support Vouchers for Psychedelic Therapies

[ Price : $8.95]

FDA commissioner Marty Makary tells Fox Business that the agency will deploy its new national priority voucher program to signific...

FDA Approves Mercks Idvynso for Treating HIV

[ Price : $8.95]

FDA approves Mercks Idvynso, a once-daily, single-tablet regimen for adults with HIV-1 who are already virologically suppressed.

Outlook Therapeutics Completes FDA Dispute Meeting on Lytenava

[ Price : $8.95]

Outlook Therapeutics completes a formal dispute resolution meeting with FDA as part of the companys push to revive its approval pr...

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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