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FDA Keeps Boxed Warning About Suicide on Chantix
2015-03-09 22:52:28| Biotech - Topix.net
The Food and Drug Administration says it will keep a bold-letter warning on Pfizer's anti-smoking drug Chantix about suicidal behavior and other psychiatric problems. Pfizer Inc. asked the agency last year to drop the so-called black box warning, pointing to its own analyses that found no difference in psychiatric problems between people taking Chantix and other stop-smoking treatments.
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warning
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Novartis Wins FDA Approval For Zarxio, First Biosimilar Drug In The US
2015-03-06 22:24:27| Biotech - Topix.net
U.S. regulators on Friday gave a green light to sales of the country's first copied version of a biotechnology drug, or "biosimilar," with approval of Novartis' white blood cell-boosting Zarxio. The drug contains the same active ingredient as Neupogen, or filgrastim, which logged 2014 worldwide sales of $1.2 billion for manufacturer Amgen.
Aerocrine Ab Receives Fda Clearance for Niox Vero BlueTooth Wireless Enhancement
2015-03-06 09:30:22| Appliances - Topix.net
Aerocrine AB announces today that clearance was received for its FeNO measuring device to operate wirelessly with BlueTooth technology in the US. The US FDA has granted Aerocrine AB regulatory clearance for NIOX VERO through a special 510k to utilize BlueTooth wireless technology to send FeNO measurements and patient data between the NIOX VERO and the healthcare providers' computers.
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FDA approves Bristol-Myers drug for lung cancer
2015-03-04 21:48:13| Biotech - Topix.net
The Food and Drug Administration on Wednesday expanded approval of an innovative Bristol-Myers Squibb drug to treat the most common form of lung cancer. Regulators cleared Opdivo for patients with advanced squamous non-small cell lung cancer, which accounts for seven out of eight lung cancer patients.
Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A
2015-03-04 21:03:00| Chemicals - Topix.net
Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults.
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