Compassionate Use of REGEN|COV

REGEN-COV FDA Approval Status - Drugs.com

The casirivimab and imdevimab antibody cocktail (REGEN-COV) received Emergency Use ... Compassionate Use Request. Sep 29, 2020, Regeneron's ...

What is REGEN-COV (casirivimab and imdevimab) and how should ...

Who is REGEN-COV for? REGEN-COV can be used for the treatment of mild to moderate COVID-19 in adults and pediatrics (age greater than ...

Definition of compassionate use - NCI Dictionary of Cancer Terms

Compassionate use allows patients to receive promising but not yet fully studied or approved cancer therapies when no other treatment option exists.

summary-compassionate-use-remdesivir-gilead_en.pdf

developed for the treatment of coronavirus (CoV) disease. Remdesivir for compassionate use is provided in two dosage forms, a solution ...

Working Group on Compassionate Use & Preapproval Access ...

“Preapproval access”, “compassionate use”, “expanded access”, “right ... CoV, among others. On August 9, 2022, a public health emergency was declared ...

REGEN-COV (EUA) Intravenous: Uses, Side Effects ... - WebMD

The combination of casirivimab and imdevimab is a product that has been used to treat COVID-19 on an emergency/interim use basis.

Compassionate Use Policy - Direct Biologics

Our compassionate use, also known as expanded access policy, consists ... gov. As authorized by the 21st Century Cures Act, Direct Biologics may revise ...

EMA provides recommendations on compassionate use of ...

Remdesivir has been shown to be active against SARS-CoV-2 and other types of coronavirus (i.e. SARS-CoV and MERS-CoV) in laboratory studies; ...

TIME TO EXPAND THE USE OF CASIRIVIMAB/IMDEVIMAB ...

Here, we present a case of compassionate use of REGEN-COV in severe COVID-19 pneumonia. CASE PRESENTATION: A 76-year-old male with a medical ...

ClinicalTrials.gov: Home

... gov. ClinicalTrials.gov does not indicate whether the submission was a ... Also called compassionate use. There are different expanded access types ...

Compassionate Use Programs - COVID-19 | Italian Medicines Agency

The compassionate use programs already authorised (specifying the authorisation date, medicinal product and sponsor) are as follows: 24/04/2020 - Ribavirin - ...

Sotrovimab | Emergency Use Authorization (EUA) Information for ...

Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with ...

Expanded Access & Compassionate Use - Clinical Trials - Pfizer

Find a trial on clinicaltrials.gov (all sponsors, including Pfizer Inc.) 2. Expanded Access or Compassionate Use. In cases where a clinical trial isn't an ...

Compassionate Drug Use | Expanded Access for Cancer Drugs

... treatment. If so, the next step is to contact the FDA's Center for Drug Evaluation and Research (CDER) at 1-301-796-3400 or fda.gov/drugs or ...

Casirivimab/imdevimab - Wikipedia

Casirivimab/imdevimab, sold under the brand name REGEN‑COV among others, is a combination medicine used for the treatment and prevention of COVID‑19.

Stein 2021e - Cochrane COVID-19 Study Register

Compassionate Use of REGEN-COV(R) in Patients with COVID-19 and Immunodeficiency-Associated Antibody Disorders. Stein,D., Oviedo-Orta,E., ...

Efficacy and safety of a single dose of casirivimab and imdevimab ...

Stein, D ∙ Oviedo-Orta, E ∙ Kampman, WA ∙ et al. Compassionate use of REGEN-COV® in patients with COVID-19 and immunodeficiency-associated ...

REGEN-COV: Uses, Side Effects, Dosage & Reviews - GoodRx

REGEN-COV was given emergency use authorization by the FDA to treat mild-to-moderate coronavirus disease 2019 (COVID-19) or prevent COVID-19 infections.

The Art of Basic Science | Brandeis Magazine

At the time, REGEN-COV was approved for “compassionate use” only. One month later, the FDA authorized using the drug to treat COVID-19 in high-risk patients ...

Expanded Access Policy | ImmunoGen ADC Technology-focused ...

... compassionate use, early access, pre-approval access, or emergency use. ... gov and search “expanded access programs.” Back to Top. Contact Us · Privacy ...