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Now Alli Joins Plan B to Embarrass FDA into Action?

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Washington commentator Bob Steeves reviews new risk data on orlistat and contrasts its continuing OTC availability to teens with e...

Janssen Files NDA for Diabetes Combo Pill

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Janssen files an NDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate-release metformin to treat pa...

Higher CV Risk Seen in Chantix Patients

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FDA says a higher occurrence of major adverse cardiovascular events was observed in patients using Pfizer's smoking cessation aid ...

FDA Accepts Takeda/Lundbeck NDA for Brintellix

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FDA accepts for review a Takeda and H. Lundbeck NDA for Brintellix for treating major depressive disorder in adult patients.

Advisors Asked About Drug Teratogenic Risk

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FDA releases discussion points on managing drug teratogenic risk for a rescheduled meeting of the Drug Safety and Risk Management ...

CDER Staff Worried About Late-Cycle Meetings: Jenkins

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CDER Office of New Drugs director John Jenkins says his staff are worried about the outcomes from the addition of late-cycle meeti...

FDA Approves Sucampo sNDA for Rescula

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FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula 0.15% for lowering intraocular pressure in patients with open-...

FDA Releases Celltex Therapeutics Inspection Results

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FDA releases the FDA-483 containing 14 inspection observations issued after an April inspection at Celltex Therapeutics.

Pfizer Pays $55 Million to Settle Protonix Off-label Activities

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Pfizer agrees to pay $55 million plus interest to resolve allegations that its Wyeth subsidiary illegally introduced into intersta...

Natus Medical Olympic Cool-Cap System Recall is Class 1

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FDA says the Natus Medical recall of the Olympic Cool-Cap System due to the potential for unexpected power failure and lack of coo...