IDx, a privately held AI diagnostics company, announced today that it has filed its De Novo submission to the FDA for IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy — a leading cause of blindness. The FDA has granted IDx-DR with a “Breakthrough Device” designation, which means the submission will receive expedited review.
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of moderately-to-severely active rheumatoid arthritis (RA) for adult patients who have had an inadequate response or intolerance to methotrexate. While the Advisory Committee unanimously supported the efficacy of the 4-mg dose of baricitinib, it did not recommend approval of the 4-mg dose of baricitinib for the proposed indication based on the adequacy of the safety and benefit-risk profiles.
The mHealth app, designed by researchers at the Worcester Polytechnic Institute, helps obstetric care providers identify perinatal depression in soon-to-be and new mothers and gives them care management tips.
Cambridge, Ma. -- Shire plc, the global biotechnology leader in rare disease, today announced the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD).
Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
your submission has already been received.
Please enter a valid Email address！
The most relevant industry news & insight will be sent to you every two weeks.