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Human Drugs

DermaSensor AI Skin Cancer Detector Cleared

FDA clears DermaSensor's real-time, skin cancer evaluation system.

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Human Drugs

FDA Extends Narcan Shelf Life

FDA extends the shelf life of Emergent BioSolutions newly manufactured Narcan (naloxone HCl) 4 mg nasal spray products from three years to four years....

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Human Drugs

Reschedule Marijuana to Schedule 3: FDA

FDA recommends that the Drug Enforcement Administration down-classify marijuana from Schedule 1 to Schedule 3 under the Controlled Substances Act.

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Human Drugs

Nurix Therapeutics Gets Fast Track Status

FDA grants Nurix Therapeutics a fast track designation for NX-5948 for treating certain adult patients with relapsed or refractory chronic lymphocytic...

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Federal Register

Info Collection on New Dietary Ingredients

Federal Register notice: FDA revises an information collection entitled Premarket Notification for a New Dietary Ingredient (NDI) 21 CFR 190.6.

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Medical Devices

Multiple Violations at Dr. Joel Kaplan Inc.

FDA warns San Diego, CA-based Dr. Joel Kaplan Inc. about multiple violations in its manufacturing and distribution of several devices intended to enha...

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Docs Dont Understand FDA Approval Process: Research

A physician survey conducted by UCSF researchers finds many doctors dont understand how FDA approves new drugs and medical devices.

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Human Drugs

Hemogenyx Responds to Clinical Hold

Hemogenyx Pharmaceuticals files its complete response to an FDA HEMO-CAR-T clinical hold in hopes of starting Phase 1 trials.

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Human Drugs

Clinical Trial Modernization and Innovation Meeting

FDA publishes the summary of an October 2023 public meeting on continuing the Covid-19 lessons learned for modernization and innovation in clinical tr...

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Biologics

Vertex Pharma Gets 2nd OK for Gene Therapy

A month after gaining FDA approval for treating sickle cell disease with the gene therapy Casgevy, Vertex secures its second approval for treating tra...