Polyganics, a privately held medical technology company that develops, manufactures and commercializes bioresorbable medical devices, announced that the US Food and Drug Administration (FDA) has granted Polyganics’ request for Breakthrough Device designation to its Liver and Pancreas Sealant Patch. The Liver and Pancreas Sealant patch is considered a unique breakthrough in the prevention of fluid leakage after hepato-pancreato-biliary (HPB) procedures, for which currently no approved or cleared alternatives exist.
The FDA has slapped a clinical hold on a combo therapy using Advaxis’$ADXS axalimogene filolisbac along with AstraZeneca’s approved PD-L1 Imfinzi following the death of a patient in their Phase I/II trial.
Pfizer Inc. announced a positive outcome from today’s U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting. The GIDAC met to discuss Pfizer’s supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
Shares of Laval, Quebec-based ProMetic Life Sciences Inc. jumped more than 8.7 percent this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation for its Inter-Alpha-Inhibitor-Proteins (IAIP) treatment for necrotizing enterocolitis (NEC).
The U.S. Food and Drug Administration expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
Qualcomm Life announced an exclusive licensing agreement with AlertWatch, creator of an FDA-cleared intelligence care software that assists in the care of patients in the operating room. The deal will give Qualcomm Life the exclusive rights to sell AlertWatch, which the company plans to showcase at HIMSS 2018.
Vertex Pharmaceuticals Incorporated (VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor. SYMDEKO is Vertex’s third medicine approved to treat the underlying cause of CF. Vertex is ready to launch SYMDEKO and will begin shipping it to pharmacies in the United States this week.
Cognoa has gained regulatory recognition for its machine learning software as a class II diagnostic medical device for autism — meaning the digital health startup is now positioned to submit an application for full FDA clearance.
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