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monoclonal antibodies

FDA Approves Enflonsia, Second RSV Antibody for Infants

The FDA has approved the second monoclonal antibody for the prevention of RSV in neonates and infants, ...

JUNE 10, 2025

FDA Approves Fasenra for EGPA

The FDA approved Fasenra for adults with eosinophilic granulomatosis with polyangiitis.

SEPTEMBER 19, 2024

FDA Approves Veopoz for CHAPLE Disease

The FDA approved Veopoz as the first treatment for CD55-deficient protein-losing enteropathy, also known as CHAPLE ...

AUGUST 21, 2023

Navigating the Pandemic With EUA Therapies

Infusion and specialty pharmacies have been playing a critical role in navigating a frequently changing menu of ...

AUGUST 23, 2022

FDA Expands Authorization for Evusheld; Authorizes Bebtelovimab for COVID-19

The FDA revised the EUA for tixagevimab-cligavimab to allow a higher dose for PrEP and also granted a new EUA to ...

MARCH 1, 2022

Arsenal Against Omicron Weakening

At least two Mabs available under the FDA emergency use authorization are not as effective against omicron as ...

JANUARY 12, 2022

Pharmacists Authorized to Order and Administer COVID-19 Therapeutics Under PREP Act Declaration

An amendment to the PREP Act broadly addresses the pharmacist's role in providing COVID-19 therapeutics, including ...

SEPTEMBER 16, 2021

FDA Authorizes Use of Actemra for COVID-19

The FDA issued an EUA Actemra to treat hospitalized adults and children who are receiving systemic corticosteroids ...

JUNE 28, 2021

FDA Revokes EUA for Bamlanivimab Monotherapy for COVID-19; Still Authorized in Combination

Although the FDA revoked its EUA for bamlanivimab monotherapy, the agency said it could still be given ...

APRIL 21, 2021

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