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Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

In 2001, the FDA issued a guidance to “alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.” It also proposed several packaging changes to safeguard against misidentification. However, the medical gas industry still had a bone to pick with FDA.

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New England Journal of Medicine Publishes Positive Initial Regeneron Antibody Cocktail Results in Non-hospitalized Patients with COVID-19

The Pharma Data

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Have chronic kidney disease. Have diabetes.

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Regeneron Announces U.S. Government Agreement to Purchase Additional COVID-19 Antibody Cocktail Doses

The Pharma Data

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. Definition of High-Risk Patients. Have chronic kidney disease. Have diabetes.

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Regeneron Announces Encouraging Initial Data from COVID-19 Antibody Cocktail Trial in Hospitalized Patients on Low-flow Oxygen

The Pharma Data

AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION Authorized Emergency Use 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.

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Regeneron’s Casirivimab and Imdevimab Antibody Cocktail for COVID-19 is First Combination Therapy to Receive FDA Emergency Use Authorization

The Pharma Data

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. Definition of High-Risk Patients. REGN-COV2 (casirivimab and imdevimab) FDA Approval History.

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Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

The Pharma Data

Casirivimab and imdevimab injection (REGEN-COV2) 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. Definition of High-Risk Patients. Have chronic kidney disease. Have diabetes.

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CAPTIVATE Study Shows an IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Chemotherapy-Free Combination Has Potential to Provide Remission After Fixed-Duration Treatment for Chronic Lymphocytic Leukemia (CLL)

The Pharma Data

Patients who did not meet the definition of confirmed uMRD were randomized 1:1 to receive open-label treatment with ibrutinib or continued ibrutinib + venetoclax. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. Advise nursing women to discontinue breastfeeding during treatment. 2012;119(11):2590-2594.