Regulatory Affairs Syndicator

Enews 2.0Anthrax Ruling to Be AppealedWashington Post, United States - 7 hours ago… court to block the Pentagon from inoculating the plaintiffs and to rule that the vaccine was improperly licensed by the Food and Drug Administration. …Jud…

PravdaUS Food and Drug Administration Approves ABILIFY(R) (aripiprazole …Earthtimes, UK - 16 hours ago29 — Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced today that the US Food and Drug Administration (FDA) appr…

Enews 2.0Baxter Recalls Rest of Heparin ProductsForbes, NY - 1 hour ago"We have assurance from the US Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and …Baxter recalls…

KPICGERD Drug Approved for Younger ChildrenForbes, NY - 14 hours ago… disease (GERD) in adults, has been approved for the same short-term use in children ages 1 to 11, the US Food and Drug Administration said Thursday. …FDA OKs Nexium in …

Drug Study Results Hidden by the Food and Drug Administration May …Web Services Journal, NJ - 12 hours ago… most negative drug study results are hidden from doctors by the food and drug administration (FDA), leaving doctors in the dark ab…

The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.

The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

RTE.ieBiogen, Elan drug liver issues not new - US FDAGuardian Unlimited, UK - 2 hours ago… Elan Corp Plc's Tysabri drug was added to the label in January and is not a new issue, a US Food and Drug Administration spokeswoman said on Wedn…

Kristalose(R) Offers Prescription Alternative to MiraLAX(R) and …FOXBusiness - 5 hours agoDue to US Food and Drug Administration policy which does not allow the same formulation of a product to be marketed simultaneously as both a prescription …

Osiris launches heart disease drug trialBizjournals.com, NC - 2 hours agoOsiris (NASDAQ: OSIR) said it received approval for the Phase II trial of Prochymal from the US Food and Drug Administration. …Osiris Stock Up on Heart Drug Study Data…

Al-ArabiyaAntidepressants no better than placebo for most, study saysSydney Morning Herald, Australia - 5 hours ago… drugs known as selective serotonin reuptake inhibitors which had been presented to the US Food and Drug Administration as p…

Chinese drug maker defends plant's safetyLos Angeles Times, CA - 4 hours agoBaxter's Chinese supplier, Changzhou SPL — a joint venture with a Wisconsin company — was never inspected by the Food and Drug Administration, …

Ahead of the Bell: Pharmaceutical suitsBusinessWeek - 2 hours agoInstead, it focuses on a specific issue: whether state courts can consider allegations that a drug company misled the Food and Drug Administration to win …

Mass food poisoning outbreakShanghai Daily, China - 16 hours agoOfficials from Shanghai Food and Drug Administration said victims had eaten lunch and supper provided by Hongyang on Saturday. Employees in other shifts ate …City begins to tra…

More Help for the HeartWall Street Journal - 5 hours ago… "sufficient scientific evidence" to cover the devices, as long as they are used as part of clinical trials approved by the Food and Drug Administration. …