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Human Drugs

FDA Accelerated Approval for BMS Augtyro Cancer Drug

FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyrosine receptor kinas...

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Medical Devices

Megadyne Recalls Pediatric Return Electrodes

Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned during electrosurgery ...

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Human Drugs

3 Bayesian Examples Added to Demonstration Project

FDA adds three Bayesian statistical analysis examples to the CDER Center for Clinical Trial Innovation Web page.

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Human Drugs

Supreme Court Rejects Mifepristone Lawsuit

The U.S. Supreme Court 6/13 unanimously rejects a lawsuit seeking to sharply restrict distribution of the chemical abortion pill mifepristone (Dancos ...

Biologics

FDA Revises Covid Vaccine Composition Recommendation

FDA updates its advice on this falls Covid-19 vaccine composition based on a recent review of circulating Covid cases in the U.S.

Biologics

Submit Long Covid Drug as IND: FDA

FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.

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Federal Register

Drug Distribution Security Comment Period Reopened

Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better understand the status of t...

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Federal Register

Info Collection on Drug Compounding

Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, and Related Activitie...

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Human Drugs

5 Teva ProAir Patents Ordered Out of Orange Book

A New Jersey federal judge orders five Teva ProAir patents removed from the FDA Orange Book.

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Human Drugs

FDA Platform Technology Designation Analyzed

Two Morgan Lewis attorneys analyze a recent FDA guidance on how it will implement its drug platform technology designation program.