The Pharma Data

NOVEMBER 20, 2020

Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need. Casirivimab and imdevimab injection is not FDA approved for any use.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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Vaccine FDA Clinical Trials Disease 52

Agency IQ

OCTOBER 6, 2023

BY AMANDA CONTI | OCT 4, 2023 10:40 PM CDT A quick note: How AgencyIQ gathers data on drug approvals AgencyIQ reviews drug approvals from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). government fiscal year runs from October 1 – September 30. What’s next?

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The Pharma Data

NOVEMBER 21, 2020

government allocation program. Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need. government and Regeneron signed an agreement for this initial supply of REGEN-COV2.

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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. are scheduled to receive a vaccine. If you are not sure about the type of immunization or vaccine, ask your healthcare provider.

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Treatment FDA FDA Approval Therapies 40

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. are scheduled to receive a vaccine. If you are not sure about the type of immunization or vaccine, ask your healthcare provider.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

MAY 5, 2021

. White House will make unordered vaccine supply available to other states ( WaPo ). White House set to send vaccines abroad ( Politico ). cases, vaccinations continue to drop as White House sets new inoculation goal ( CNBC ). BD Taps Contract Packager for COVID-19 Test Kits ( MD+DI ).

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection. TARRYTOWN, N.Y., NASDAQ: REGN) announced today that the U.S.

FDA Approval 52

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Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Polansky v. 3d 239 (Cal.

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