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Latest approval news and updates

Money Matters - Simplified

approval

DULERA gets FDA's approval

Merck, a global healthcare leader well-known as MSD outside the United States and Canada, announced the approval of DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol by the United States Food and Drug Administration (FDA).

DULERA Inhalation Aerosol is a new fixed-dose combination asthma treatment for patients 12 years of age and older. But it is not indicated for the relief of acute bronchospasm.

DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate).

Pfizer pulls cancer drug Mylotarg from US market

Mulling over the efficacy and safety concerns of gemtuzumab ozogamicin (Mylotarg), the drug for the treatment of acute myeloid leukemia (AML), a type of bone marrow cancer, Pfizer announced on Monday that it is withdrawing it from the U.S. market at the request of the Food and Drug Administration (FDA).

FDA gives thumbs down to ‘Female Viagra’

The German pharmaceutical company, Boehringer Ingelheim, got a body blow Friday when a federal advisory panel unanimously voted down its application for the approval for flibanserin, a drug meant to cure hypoactive sexual-desire disorder, or HSDD, in pre-menopausal women.

FDA approves new drug Jevtana for advanced prostate cancer

A chemotherapy drug, which not only offers better treatment but also promises to lengthen the survival by two and half months in men suffering from advanced prostate cancer, has been approved by the U.S. Food and Drug Administration (FDA).

Studies on ‘Female Viagra’ disappointing

It is being pegged as the female Viagra, a drug that would treat low-sex drive in women.

FDA approves Novartis' first oral multiple sclerosis drug

The U.S. Food and Drug Administration (FDA) advisory panel approved the first line treatment for multiple sclerosis (MS) Gilenia is the first oral drug that Novaritis, a German drug maker, would sell under this brand name.

Amgen's anti-osteoporosis drug, Prolia wins FDA approval

Amgen received approval from the U.S. Food and Drug Administration (FDA) for marketing the drug, Prolia, it has developed to treat and prevent bone loss in postmenopausal women who are at increased risk of fractures.

Google says no to Windows

Internet search giant, Google, has banned the use of Microsoft's Windows operating system (OS) for internal use at its office, as reported by the Financial Times. Google took this decision after the Chinese hacking incident.

FDA clears use of rotavirus vaccine for infants

The popular baby vaccine, Rotravix, for preventing rotavirus has been deemed safe with no dangerous side effects by the US Food and Drug Administration (FDA) and doctors have been urged to resume administrating it as part of a regular vaccination schedule.

FDA approves new drug to treat Gaucher

Due to the short supply of Cerezyme, the only approved drug for the rare genetic disorder Gaucher, the U.S. Food and Drug Administration (FDA) gave the nod to a new drug Velaglucerase Alfa for injection, (trade name VPRIV), manufactured by Shire Human Genetic Therapies Inc. for pediatric and adult treatment.


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