Search Results for “FDA” – Page 66 – 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
- 685
- 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
- 600
- March 9, 2018
FDA NEC
J&J CIO touches on FDA pre-cert pilot program, artificial intelligence and innovation

Stuart McGuigan took on his role as CIO of industry behemoth Johnson & Johnson in 2012. That was around the same time that Alex Gorsky joined the company as CEO. Since then, part of Gorsky’s mission has been to help J&J focus on technology, McGuigan said in an interview at HIMSS this week.
- Source: MedCityNews
- 678
- March 9, 2018
AI Company Insight healthcare technologies and innovations
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
- 635
- March 9, 2018
FDA heart valves medical device New Approvals
Panther gets FDA nod for bone fixation device

Panther Orthopedics has won FDA approval for its implantable orthopedic fixation device. The 510(k) nod clears Panther to sell a device designed to deliver continuous compression during bone healing while allowing joint motion.
- Source: FierceBioTech
- 508
- March 9, 2018
Company Insight medical device products Orthopaedics
FDA approves new HIV treatment for patients who have limited treatment options

Today, the U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
- Source: Prnewswire
- 482
- March 8, 2018
antiretroviral HIV New Approvals
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA Clearance of the First and Only 1.0mm Coronary Balloon in the U.S.

Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the OrbusNeich® 1.0mm Sapphire® II PRO coronary balloon.
- Source: Enhancedonlinenews
- 491
- March 5, 2018
artery disease New Approvals Sapphire
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
- 679
- 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
- 461
- 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.
- 555
- March 1, 2018
cystic fibrosis FDA New Approvals SYMDEKO™

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