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December 21, 2022
Bylvay has minimal systemic exposure and acts locally in the small intestine as a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi).
The MAA is supported by data from the pivotal Phase III GEMSTONE-302 trial that evaluated treatment with sugemalimab in combination with chemotherapy in patients with metastatic NSCLC.
December 20, 2022
FDA has announced that bebtelovimab is not currently authorized for emergency use in any region of the US.
December 14, 2022
The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.
December 08, 2022
FDA struggles to track shortages caused by a rise in demand.
December 07, 2022
Ferring Pharmaceuticals’ Rebyota was approved for the prevention of recurrence of Clostridioides difficile infection.
December 03, 2022
QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability.
December 02, 2022
The European Human Medicines Directive and Regulation is due to be updated by the end of 2022, but what changes are on the cards?
Health crises, political tension, and budget concerns were major challenges.
November 28, 2022
CSL’s Hemgenix (etranacogene dezaparvovec) will cost approximately $3.5 million, making it the most expensive single-use medicine in the United States.