💊FDA Issues Priority Review Voucher for EBANGA Medical Countermeasure
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EBANGA (ansuvimab-zykl) for injection, approved on December 21, 2020, manufactured by Ridgeback Biotherapeutics, LP, meets the criteria for a material threat MCM priority review voucher.
Learn More⚖️DEA Revocation Decision Impacting De Novo Services, LLC
The Drug Enforcement Administration (DEA) has issued an order revoking the registration of De Novo Services, LLC due to substantial violations in managing controlled substances and maintaining proper recordkeeping. The decision underscores the stringent compliance requirements enforced by federal regulations to protect public health and safety, highlighting the consequences of non-adherence.
Learn More💉Exclusive Patent License Opportunity for Cancer Treatment Drug Delivery
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the patents applications listed in the Supplementary Information section of this notice to Sangam Lifesciences, Inc. (Sangam), a company located in Denver, Colorado.
Learn More💊FDA Approves TREMFYA Under Rare Pediatric Disease Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-24) for TREMFYA (guselkumab), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Learn More💊FDA Decision on MOBIC Allows Continued Generic Approvals
The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More💊DEA Notice
Research Triangle Institute has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Notice for Controlled Substances Importer Application by Scottsdale Research Institute
Scottsdale Research Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More⚖️Restek Corporation's Bulk Manufacturer Application for Controlled Substances
Restek Corporation has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Notice of Application for Controlled Substances by Myonex LLC
Myonex LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Executive Order on Lowering Drug Prices and Its Business Implications
Executive Order 14273 seeks to restore prior initiatives aimed at lowering prescription drug prices in the U.S. The order emphasizes transparency in drug pricing, encourages competition through generics, and addresses the Medicare Drug Price Negotiation Program to enhance access to affordable medications while fostering innovation in the pharmaceutical industry.
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