PolarityTE Reports Fiscal Year 2021 Financial Results and Provides Business Update

SALT LAKE CITY, March 30, 2022 /PRNewswire/ — PolarityTE, Inc. (Nasdaq: PTE) a biotechnology company developing regenerative tissue products and biomaterials, today provided a business update and reported financial results for the twelve-month period ended December 31, 2021. Recent Business and Financial Updates In the first quarter of 2022, PolarityTE received approval from the U.S. […]

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MDUFA V Agreement Reached

The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for MDUFA V. On March 22, FDA sent the commitment letter to Congress. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years. FDA could receive additional funding […]

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