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FDA issues a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the companys product...[ Price : $8.95]
FDA extends by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in com...[ Price : $8.95]
FDA releases the form FDA-483 issued following an inspection at the Vet4U drug distribution facility in Clay, NY.[ Price : $8.95]
An unidentified major drug company calls on FDA to establish a process for redacting complete response letters for unapproved appl...[ Price : $8.95]
Senate Democrats, led by Ron Wyden (D-OR), introduce legislation aimed at forcing the Trump administration to disclose the terms o...[ Price : $8.95]
FDA denies a citizen petition seeking to withdraw approval of Covidiens VenaSeal vein-closure system, concluding the medical devic...[ Price : $8.95]
FDA approves an expanded indication for Sanofis Tzield (teplizumab), allowing its use in children as young as one year old to dela...[ Price : $8.95]
FDA warns Chinas Xiamen Kang Zhongyuan Biotechnology Co. about producing drugs in insanitary conditions and making misleading or d...