Approval

FDA Withdrawn Approval for Some Cholesterol Lowering Drugs

FDA Withdraw The Approval of Niacin and Fenofibric Announced in the Federal Register on April 18, 2016, the U.S. Food and Drug Administration (FDA) disclosed their decision to withdraw earlier [...]

FDA Drug Approvals on the Rise

Data shows that the U.S. Food and Drug Administration (FDA) is approving most drugs that come their way. BioMedTracker, a division of publishing giant Informa that helps investors track events [...]

FDA Mistakenly Expands Approval For Sleep Drug

Sleep Drug Under Scrutiny. When the Food and Drug Administration (FDA) gave approval for Hetlioz (tasimelteon), a drug to treat non-24 sleep-wake disorder, a rare condition, the agency may have [...]

FDA Approval Does Not Guarantee that Drugs are Safe or Effective

Approval Does Not Guarantee Drugs Safety. When the U.S. Food and Drug Administration (FDA) approves a drug, it does not necessarily mean that the drug is safe or effective for [...]

Qsymia Approval Raises Safety Worries

Widespread Concerns Over Qsymia Diet Drug Safety. A new prescription obesity and diet drug has been approved for use in the U.S. and like many of its predecessors, there [...]

AstraZeneca Experiences Approval Delays

AstraZeneca Experiences Approval Delays. The release of asthma drug, Symbicort, is being delayed for approval to young children. Reuters said that regulators have asked Symbicort maker, AstraZeneca Plc, for additional [...]

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