Food and Drug Administration (FDA)
NEWS
September has been a relatively slow month for the U.S. Food and Drug Administration. However, there are two PDFUA dates remaining, although one of those took an unexpected turn that will delay it until later in the year.
Nucala is the only targeted biologic to be approved for the condition in the six to 11-year age group in the United States, the company said.
The approval marks the first commercial product for Xeris.
Ultragenyx Pharmaceutical Inc. and Kyowa Kirin Co., Ltd. announced plans to submit a supplemental Biologics License Application to the U.S. Food and Drug Administration for Crysvita® for the treatment of FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research.
The U.S. Food and Drug Administration (FDA) gave the thumbs-up to Boehringer Ingelheim’s Ofev (nintedanib) for systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Global Blood Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) seeking accelerated approval for voxelotor, an oral, once-daily therapy in development for the treatment of sickle cell disease (SCD).
Recce Pharmaceuticals Ltd announced advances in scaled manufacture and drug quality following positive Food and Drug Administration feedback to its Chemistry, Manufacturing, and Controls data pack.
GeneTx Biotherapeutics LLC and Ultragenyx Pharmaceutical Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation and Rare Pediatric Disease Designation to GTX-102 for the treatment of Angelman Syndrome, a serious, debilitating rare neurogenetic disorder that affects approximately 1 in 15,000 people worldwide.
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