The FDA's Center for Devices and Radiological Health plans to expand its digital health pre-certification pilot program by the end of 2018, the center's associate director for digital health Bakul Patel said March 22, according to Regulatory Focus.
This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
Medtronic has finally received FDA clearance for Guardian Connect, its smartphone-connected standalone CGM for patients who use multiple daily injections (MDI) for their insulin. Medtronic's closed-loop system for pump users was cleared in 2016.
Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Bristol-Myers Squibb Company (BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for this application, which is the 2nd indication for which the Opdivo plus Yervoy combination has received this designation.
Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
Bayer today announced that its collaboration partner Loxo Oncology, Inc., (NASDAQ: LOXO), a biopharmaceutical company based in Stamford, Connecticut (US), has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA Priority Review designation; provides clinicians with pediatric-specific safety and clinical data Novartis continues commitment to people living with CML, including pediatric patients with this cancer
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