FDA – Page 10 – media

Pfizer Announces Favorable Outcome of FDA Advisory Committee Meeting on XELJANZ® (tofacitinib) for Moderately to Severely Active Ulcerative Colitis

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).
- Source: finance.yahoo
- 707
- March 12, 2018
FDA Pfizer UC XELJANZ
Prometic Snags Rare Pediatric Disease Designation from the FDA for its Inter-Alpha-Inhibitor-Proteins

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).
- Source: biospace
- 614
- March 9, 2018
FDA NEC
FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world

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.
- Source: FDA
- 650
- March 9, 2018
FDA heart valves medical device New Approvals
Qualcomm Life signs deal with AlertWatch, PeriGen

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.
- Source: MobiHealthNews
- 582
- March 2, 2018
digital health FDA Market Views
Celgene shaken again after the FDA kicks back their marketing application on blockbuster hopeful ozanimod

Celgene has been slammed with a refuse-to-file letter from the FDA for ozanimod, the biggest late-stage drug it has in the pipeline.
- Source: endpts
- 690
- March 2, 2018
Celgene FDA multiple sclerosis ozanimod
Galera Therapeutics Receives FDA Breakthrough Therapy Designation for GC4419 for the Reduction of Severe Oral Mucositis

Designation Based on Positive Results of Phase 2b Trial of GC4419 Severe Oral Mucositis Affects 70 Percent of Head & Neck Cancer Patients Receiving Radiotherapy
- Source: 4-traders
- 472
- March 2, 2018
FDA New Approvals severe oral mucositis SOM
FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

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.
- Source: finance.yahoo.
- 569
- March 1, 2018
cystic fibrosis FDA New Approvals SYMDEKO™
Cognoa’s AI platform for autism diagnosis gets first FDA stamp

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.
- Source: Techcrunch
- 607
- February 27, 2018
AI autism FDA New Approvals
U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Gilead Sciences, Inc.(NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.
- Source: gilead
- 911
- February 26, 2018
Biktarvy FDA Gilead Sciences HIV-1 infection
FDA Orders Recall of Drug Dosage mHealth App for Diabetic Patients

The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
- Source: mHealth Intelligence
- 784
- February 26, 2018
diabetes FDA mHealth Policies

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