marketing authorization application

FDA will allow ZYN Nicotine pouches to stay on market

FDA 'Closely Monitoring' Zyn Nicotine Pouches After Marketing Approval

The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but will be "closely monitoring youth use." Newsweek reached out to Zyn for comment.

U.S. News & World Report · 2h

FDA Approves Marketing of Nicotine Pouches

Following an extensive scientific review, the U.S. Food and Drug Administration has authorized the marketing of 20 ZYN nicotine pouch products. Nicotine pouches -- small synthetic fiber pouches containing nicotine -- are designed to be placed between a person's gum and lip.

The Washington Post · 1d

FDA OKs sales of Zyn nicotine pouches, citing health benefits for adult smokers

Federal health officials are backing the health benefits of nicotine pouches, ruling that Philip Morris International’s Zyn can help adult smokers cut back or quit cigarettes

20h

Illuccix® Receives European Approval

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate ...

Business Wire3d

Acadia Pharmaceuticals Submits Marketing Authorization Application to the European Medicines Agency for Trofinetide for the Treatment of Rett Syndrome

SAN DIEGO--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency ...

Pharmabiz14h

InflaRx receives European marketing authorization for Gohibicto treat of SARS-CoV-2-induced acute respiratory distress syndrome

InflaRx receives European marketing authorization for Gohibicto treat of SARS-CoV-2-induced acute respiratory distress syndrome: Jena, Germany Friday, January 17, 2025, 11:00 Hrs ...

Acadia Pharmaceuticals submits trofinetide MAA to EMA

Acadia Pharmaceuticals (ACAD) announced that the company has submitted a marketing authorization application to the European Medicines Agency ...

MarketWatch24d

AstraZeneca, Daiichi Sankyo Withdraw Authorization Application for Lung Cancer Treatment in EU

AstraZeneca said it and Daiichi Sankyo decided to voluntarily withdraw the marketing authorization application in the European Union for advanced lung-cancer treatment Dato-DXd. This decision ...

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