💊FDA Regulatory Review Period for HEMGENIX Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for HEMGENIX 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 biological product.
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The Department of Justice's notice outlines changes in the BioMaP-Consortium’s membership, emphasizing compliance aspects associated with the National Cooperative Research and Production Act of 1993. Membership is open for future changes, promoting collaboration among the biopharmaceutical industry stakeholders to enhance manufacturing preparedness.
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