FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
The U.S. Food and Drug Administration has sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
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EMEA recommends suspension of the marketing authorisation of Acomplia
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).
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European Medicines Agency recommends update of product information of Tysabri
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who have been treated with the medicine.
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FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.
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FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
The U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
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European Medicines Agency recommends restricting the use of oral moxifloxacin-containing medicines
Finalising a review of the safety of moxifloxacin-containing medicines for oral use, the European Medicines Agency (EMEA) has concluded that these medicines should only be prescribed in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.
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EMEA recommendation on use of angiotensin II receptor antagonists during pregnancy
The European Medicines Agency (EMEA) has recommended that the product information of all centrally authorised angiotensin II receptor antagonists be harmonised, regarding their use during pregnancy. Following a review of the safety of these medicines during pregnancy, the EMEA's Committee for Medicinal Products for Human Use (CHMP), at its April 2008 meeting, recommended that the product information should state that the use of angiotensin II receptor antagonists should be avoided in the first three months of pregnancy.
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The U.S. Food and Drug Administration has sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage). 
The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).