United States

FDA improves access to reports of adverse drug reactions

Friday, September 29, 2017

The FDA launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

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FDA selects participants for new digital health software precertification pilot program

Wednesday, September 27, 2017

The FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

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FDA approves Symbiomix Therapeutics’ Solosec for bacterial vaginosis

Monday, September 18, 2017

Symbiomix Therapeutics announced the FDA has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.

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FDA grants Fast Track to Pluristem’s PLX-PAD for critical limb ischemia

Monday, September 18, 2017

Pluristem Therapeutics, a developer of placenta-based cell therapy products, announced that the FDA has granted Fast Track Designation to the company’s ongoing phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

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Teva’s Trisenox receives Priority Review for promyelocytic leukemia

Wednesday, September 13, 2017

Teva Pharmaceutical Industries announced the FDA has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of Trisenox (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.

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FDA halts two multiple myeloma Keytruda trials

Tuesday, September 5, 2017

Based on data from two recently halted clinical trials, the FDA is issuing this statement to inform the public, healthcare professionals and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. Keytruda (pembrolizumab) is not approved for treatment of multiple myeloma.

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