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Biologics

DBV Tech BLA for Peanut Allergy Immunotherapy

FDA accepts for review a DBV Technologies BLA for its investigational Viaskin peanut immunotherapy for treating peanut-allergic children ages four to ...

Human Drugs

Trump Claims Pharma Industry Supporting Impeachment

President Trump claims that the pharmaceutical industry is secretly plotting the demise of his presidency and supporting the current impeachment inqui...

Federal Register

Clinical Data Standards Pilot: Correction

Federal Register notice: FDA corrects a notice that appeared in 8/20 Federal Register announcing a Fit for Use Pilot Program Invitation for the Clinic...

Human Drugs

AstraZeneca Self-administration Fasenra Approved

FDA approves AstraZenecas self-administration version of Fasenra (benralizumab) Pen in a pre-filled, single-use auto-injector as an add-on maintenance...

Medical Devices

United Health Products PMA for HemoStyp

United Health Products files a PMA for HemoStyp, an absorbable hemostatic dressing for use in abdominal, cardiovascular, thoracic and vascular surgica...

Human Drugs

Breakthrough Status for Janssens Niraparib

FDA grants Janssen Pharmaceutical a breakthrough therapy designation for niraparib, an orally-administered poly ADP-ribose polymerase inhibitor, for t...

Human Drugs

Public Citizen Challenges Notion of Drug Prices Falling

Public Citizen challenges President Trumps assertion that his actions are responsible for lower drug prices.

Federal Register

Guide on Enzyme Replacement Therapy Products

Federal Register notice: FDA makes available a final guidance entitled Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment.

Human Drugs

Taxpayer Group Calls for More Relaxed FDA

The Taxpayers Protection Alliance calls on FDA to make changes in its regulation of drugs, tobacco, and foods to promote innovation and save consumers...

Human Drugs

Bioanalytical Methods Template Available

FDA announces availability of a technical specifications guidance with bioanalytical methods templates.