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Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for First Two Evolysse™ Dermal Filler Products
Last evolus, inc. earnings: 2/25 07:00 am
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US:NASDAQ Investor Relations: us.evolis.com/investor-relations
NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio of consumer brands, today announced that it has submitted the final module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the Evolysse™ Lift and Evolysse™ Smooth dermal filler products for the nasolabial fold (NLF).“We are pleased to have submitted the final module of the PMA application,” said Dr. Rui Avelar, MD, Chief Medical Officer and Head of R&D. “This submission is a key fundamental milestone for Evolus and we look forward to our continued collaboration with the Agency in the upcoming thorough review process.”Evolus anticipates that the FDA’s review process will adhere to the standard timeline, with approval expected in the second half of 2025. The submission underscores Evolus’ commitment to bringing the dermal filler products to market and its readiness to meet regulatory requireme
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- Evolus Announces Submission of Premarket Approval Application to the U.S. Food and Drug Administration for First Two Evolysse™ Dermal Filler Products [Yahoo! Finance][Yahoo! Finance]
- Evolus, Inc. (NASDAQ: EOLS) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald.[MarketBeat]
- Evolus Broadens International Presence with Launch of Nuceiva® (botulinum toxin type A) in Spain [Yahoo! Finance][Yahoo! Finance]
- Evolus Broadens International Presence with Launch of Nuceiva® (botulinum toxin type A) in Spain[Business Wire]
- Evolus Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)[Business Wire]
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- 6/11/24 - Form 8-K
- 6/6/24 - Form 4
- 6/6/24 - Form 144
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