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Crysvita BLA to be Submitted

[ Price : $8.95]

Ultragenyx and Kyowa Kirin say they will submit an sBLA for a new indication for their Crysvita in the first half of 2020.

Courts Let Companies Keep Drug Risks Secret: Reuters

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A Reuters investigative report examines the way in which a federal court allowed Merck to keep some Propecia risk information secr...

Hospira Recalls 1 Lot of Bacteriostatic Water

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Hospira recalls one lot of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns.

FDA Aims to Ban Flavored e-Cigarettes

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FDA moves to ban non-tobacco-flavored e-cigarettes at the urging of President Trump during a 9/11 White House meeting with acting ...

Nerlynx sNDA for 3rd-line HER2 Breast Cancer

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FDA accepts for review a Puma Biotechnology supplemental NDA for Nerlynx (neratinib) in combination with capecitabine for treating...

Electrostimulation Device a 'Breakthrough': FDA

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FDA grants Checkpoint Surgical a breakthrough device designation for the companys brief electrostimulation therapy system for nerv...

Fabulous Science is Not Enough: Woodcock

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CDER director Janet Woodcock challenges medical researchers to change the system in ways that will help bring more drugs to more p...

Hangzhou Badi CGMP Violations

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FDA warns Chinas Hangzhou Badi Daily Use Chemical Company about CGMP and other violations in its manufacturing of finished drugs.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Enprani Co., and Hangzhou Badi Daily Use Chemical.

Public Citizen Sues FDA Seeking Cesium Chloride Ban

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Public Citizen 9/10 sues FDA in Washington, DC federal court over the agencys inaction to respond to the groups 7/2018 citizen pet...