FDA warns companies to stop MRSA claims
The U.S. Food and Drug Administration has issued four warning letters to companies selling over-the-counter drug products, including hand sanitizers, telling them to stop…
News
FDA approves contrast agent for CNS MRI scans
The U.S. Food and Drug Administration has approved Gadavist (gadobutrol), a contrast agent for use in patients undergoing magnetic resonance imaging (MRI) of the…
FDA approves new treatment for metastatic melanoma
The U.S. Food and Drug Administration has approved Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm.
FDA approves new drug for lupus
The U.S. Food and Drug Administration has approved Benlysta (belimumab) for treatment of lupus. The FDA last approved a drug for lupus in 1955.…
FDA warning for terbutaline in preterm labor
The U.S. Food and Drug Administration issued a warning that terbutaline, indicated for asthma, bronchitis, and emphysema, should not be used in pregnant women…
FDA approves new drug for COPD
The U.S. Food and Drug Administration has approved roflumilast, an oral drug that reduces exacerbations from severe chronic obstructive pulmonary disease (COPD). Read more…
FDA approves drug to reduce risk of preterm birth
The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery in pregnant women with…
FDA looks to improve medical device review process
The U.S. Food and Drug Administration plans to implement changes in 2011 designed to improve review of medical devices. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm240418.htm.
FDA approves head lice treatment
The U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice in patients 4 years and…
FDA advises women with breast impants
The U.S. Food and Drug Administration says women with breast implants may have a “very small, but increased risk” of developing anaplastic large cell…
Metronidazole recall announced
The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals, USA is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration date 05/2012…
FDA recommends removing Avastin’s breast cancer indication
The U.S. Food and Drug Administration (FDA) is recommending that the breast cancer indication for Avastin be removed from its label “because the drug…
FDA warns companies to stop MRSA claims
The U.S. Food and Drug Administration has issued four warning letters to companies selling over-the-counter drug products, including hand sanitizers, telling them…
FDA approves contrast agent for CNS MRI scans
The U.S. Food and Drug Administration has approved Gadavist (gadobutrol), a contrast agent for use in patients undergoing magnetic resonance imaging (MRI)…
FDA approves new treatment for metastatic melanoma
The U.S. Food and Drug Administration has approved Yervoy (ipilimumab) for the treatment of patients with metastatic melanoma. Read more at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm1193237.htm.
FDA approves new drug for lupus
The U.S. Food and Drug Administration has approved Benlysta (belimumab) for treatment of lupus. The FDA last approved a drug for lupus…
FDA warning for terbutaline in preterm labor
The U.S. Food and Drug Administration issued a warning that terbutaline, indicated for asthma, bronchitis, and emphysema, should not be used in…
FDA approves new drug for COPD
The U.S. Food and Drug Administration has approved roflumilast, an oral drug that reduces exacerbations from severe chronic obstructive pulmonary disease (COPD).…
FDA approves drug to reduce risk of preterm birth
The U.S. Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery in pregnant…
FDA looks to improve medical device review process
The U.S. Food and Drug Administration plans to implement changes in 2011 designed to improve review of medical devices. Read more at…
FDA approves head lice treatment
The U.S. Food and Drug Administration has approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice in patients 4…
FDA advises women with breast impants
The U.S. Food and Drug Administration says women with breast implants may have a “very small, but increased risk” of developing anaplastic…
Metronidazole recall announced
The U.S. Food and Drug Administration (FDA) announced that Teva Pharmaceuticals, USA is voluntarily recalling Metronidazole Tablets USP, 250mg, lot 312566, expiration…
FDA recommends removing Avastin’s breast cancer indication
The U.S. Food and Drug Administration (FDA) is recommending that the breast cancer indication for Avastin be removed from its label “because…