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Federal Register

Padcev-Keytruda Combo for Broader Bladder Cancer

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

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Human Drugs

FDA Updates Guide on Expanded Access to Investigational Drugs

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

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Human Drugs

Nektar Reports Favorable Data in Alopecia Areata Study

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

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Human Drugs

FDA Sets Higher Approval Bar for Passage Bio Dementia Therapy

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

Medical Devices

Philips Wins Clearance for AI-powered Spectral CT System

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

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Human Drugs

Guidance on Impurity Standards For Fermentation-Based Antibiotics

FDA posts a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthet...

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Federal Register

FDA Streamlined Compliance Policy for Certain Respirators

FDA issues a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by ...

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Human Drugs

Opna Bio Wins FDA Fast Track for Multiple Myeloma Drug

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

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FDA General

Collins Presses for Faster Generic Competition at Hearing

U.S. Sen. Susan Collins (R-ME) uses a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing ...

Human Drugs

FDA Satellite Labs Block Illegal Drugs: Batson

FDA satellite laboratories branch director JaCinta Batson touts the value of the laboratories work in international mail facilities to stop illegal an...