Notice 29 Sep 2025 patent extension, pharmaceutical regulation, biologics, fda, niktimvo

💊FDA Notice on NIKTIMVO Patent Extension Review Period

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NIKTIMVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

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Notice 29 Sep 2025 patent extension, pharmaceuticals, fda, regulatory compliance, healthcare, drug approval

💊FDA Announces Regulatory Review Period for MIPLYFFA Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MIPLYFFA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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Notice 29 Sep 2025 patent extension, fda, regulatory compliance, healthcare, medical devices

🏥FDA Notice on Patent Extension for DIAMONDBACK 360 Device

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

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Notice 26 Aug 2025 compliance, pharmaceuticals, fda, regulatory review, patent extension

💊FDA Announces Regulatory Review Period for YORVIPATH Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YORVIPATH and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claim that human drug product.

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Notice 26 Aug 2025 regulatory compliance, fda, health, pharmaceutical, business, patent extension, sofdra

💊FDA Regulatory Review Period Determination for SOFDRA

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOFDRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claim that human drug product.

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Notice 26 Aug 2025 healthcare, pharmaceuticals, fda, regulatory review, patent extension

💊FDA Notice on Patent Extension for IQIRVO Drug Review Period

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IQIRVO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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Notice 26 Aug 2025 fda, regulatory review, biotechnology, patent extension, camzyos

💊FDA Notice on CAMZYOS Patent Extension and Review Period

The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.

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Notice 26 Aug 2025 regulation, fda, pharmaceutical, patent extension, zunveyl

🧪FDA Determines Patent Extension for ZUNVEYL Drug Product

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZUNVEYL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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Notice 26 Aug 2025 healthcare, fda, regulatory review, drug approval, patent extension

💊FDA Notice on LUMISIGHT Patent Extension Review Period

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUMISIGHT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

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Notice 26 Aug 2025 business compliance, pharmaceuticals, fda, regulatory review, patent extension, nemolizumab

💊FDA's Regulatory Review Notice for NEMLUVIO Patent Extension

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NEMLUVIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

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