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Affirm Dismissal of Lexapro Case: WLF

[ Price : $8.95]

The Washington Legal Foundation says the 2nd Circuit Court of Appeals should affirm a lower courts dismissal of a suit against For...

Rule on Right to Try Act Annual Summaries

[ Price : $8.95]

Federal Register notice: FDA issues a final rule specifying the deadline and content for submission of annual summaries under the...

Vanda Sues FDA Over Rejected Hetlioz sNDA

[ Price : $8.95]

Vanda Pharmaceuticals files a lawsuit against FDA seeking an order to compel it to publish in the Federal Register a notice of opp...

3 Observations on Aurobindo FDA-483

[ Price : $8.95]

FDA releases a form FDA-483 with three observations from an inspection at an Aurobindo active pharmaceutical ingredient manufactur...

FDA Clears Conformis Tapered Hip System

[ Price : $8.95]

FDA clears a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio.

Medtronic Recalls Electromyogram Endotracheal Tubes

[ Price : $8.95]

Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endo...

Inspection Form 483 for Alvotech Released by FDA

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FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its bi...

Texas Longhorn RX Producing Illegal Drugs: FDA

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FDA warns Texas Longhorn RXs Talon Pharmacy of Boerne, Boerne Texas, about selling adulterated compounded drug products.

$2 Million FDA Grant to Marker Therapeutics

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FDA grants $2 million to Marker Therapeutics to support the treatment arm in a Phase 2 trial of its T-cell candidate to treat pati...

Preserve Access to Compounded Hormones: APC

[ Price : $8.95]

The Alliance for Pharmacy Compounding calls on FDA to reject recommendations in a National Academies report and instead maintain p...