FDA Approval Genetics Nurses Packaging 
The Pharma Data
DECEMBER 17, 2020
To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The Pharma Data
JANUARY 12, 2021
Casirivimab and imdevimab injection is an investigational combination therapy and has been authorized by FDA for the emergency use described above. Casirivimab and imdevimab injection is not FDA approved for any use. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.
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The Pharma Data
DECEMBER 29, 2020
To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The Pharma Data
NOVEMBER 20, 2020
To develop this novel medicine, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. About Regeneron.
The Pharma Data
NOVEMBER 21, 2020
To develop REGEN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.
The Pharma Data
JUNE 18, 2021
IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Advise nursing women to discontinue breastfeeding during treatment. 5 Genetics Home Reference. 2010; 116(20): 4777–4787. April 2020.
The Pharma Data
JUNE 18, 2021
IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. Advise nursing women to discontinue breastfeeding during treatment. 4 Genetics Home Reference. Accessed May 2021. November 2020.
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