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Human Drugs

Appeals Court Backs Lipitor Case Dismissal

The 4th Circuit Court of Appeals upholds a lower court decision dismissing multi-state litigation alleging that patients contracted diabetes after tak...

Human Drugs

Mercks Keytruda Approved for Cervical Cancer

FDA approves Mercks Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with recurrent or metastatic cervical cancer with disease pro...

Human Drugs

Orphan Status for Chiesi Cell Therapy for Eye Condition

FDA grants Chiesi USA an orphan drug designation for GPLSCD01, ex-vivo expanded autologous human corneal epithelial cells containing stem cells, for t...

Medical Devices

Safety Update on Certain Heater-Cooler Devices

FDA issues a safety update on LivaNovas Stӧckert 3T Heater-Cooler System to help prevent the spread of infection related to the use of the devic...

2 Updated Medical Product Communications Guidances

FDA finalizes two guidances with recommendations on industry communications with payors and other entities.

Human Drugs

Lilly, AstraZeneca Scrap Phase 3 Alzheimers Studies

Based on disappointing data, Eli Lilly and AstraZeneca are discontinue global Phase 3 clinical trials of lanabecestat for treating Alzheimers disease....

Human Drugs

Taiwan Biotech CGMP Violations

FDA warns Taiwans Taiwan Biotech about CGMP violations in its production of finished drugs.

Heart Trial Protocol Changed: Public Citizen

Public Citizen says HHS has made changes to an NIH cardiac trial protocol and consent form to ease ethical concerns raised by the advocacy group.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes one medical product company Taiwan Biotech Company.

Human Drugs

Court Orders Bendeka Orphan Status

The DC federal court orders FDA to grant orphan drug exclusivity to Eagle Pharmaceuticals Bendeka.