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FDA Receives New Data on Risks of Anemia Drugs
The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as...

FDA Okays Samaritan's Cushing's SP-6300 IND and Clears Phase II Study
Samaritan Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has completed its regulatory review of Samaritan's IND (Investiga...

FDA Approves Kuvan for Treatment of Phenylketonuria
The U.S. Food and Drug Administration approved Kuvan (sapropterin dihydrochloride), the first drug of its kind approved to slow the effects of a rare ...

FDA Develops New Tools to Further Improve the Security of Food and Cosmetics
As part of the FDA’s comprehensive Food Protection Plan initiative, the agency today released self-assessment tools for industry to minimize the risk ...

FDA Issues Second Safety Warning on Fentanyl Skin Patch
The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a poten...

FDA Warns About Potential for Botulism in Canned Green Beans
The U.S. Food and Drug Administration (FDA) is warning consumers about a potential Clostridium botulinum (C. botulinum) contamination of canned cut gr...

FDA Approves ATS Medical's AP360 Mechanical Heart Valve
ATS Medical, manufacturer and marketer of state-of-the-art cardiac surgery products and services, today announced U.S. Food and Drug Administration (F...

FDA Approves Bystolic, a Novel Beta Blocker
Forest Laboratories and Mylan announced that the novel beta blocker Bystolic (nebivolol) was approved by the U.S. Food and Drug Administration (FDA) f...

FDA and Pharsight Continue to Collaborate Under CRADA
Pharsight Corporation, provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today provided an...

FDA Reviewing Potential Anti-Arrhythmic Claims for Ranexa
CV Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will evaluate the approval of potential a...

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