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Home » Topics » Pharmaceuticals » Submissions and Approvals

Submissions and Approvals
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Dupixent Approved in Canada for Atopic Dermatitis in Children

February 25, 2021
The new indication is the first granted for treating atopic dermatitis in patients aged six to 11, the company said. Read More
Remdesivir - drug

EMA Assessing Remdesivir for COVID-19 Expanded Indication

February 25, 2021
The drug was granted conditional marketing authorization in the EU in July 2020 for treating COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen. Read More
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Sanofi’s and Regeneron’s Libtayo Wins FDA Approval for NSCLC

February 25, 2021
The approval is the third for the drug and follows FDA priority review. Read More

Pfizer/BioNTech Pursue FDA Approval to Raise COVID-19 Vaccine Storage Temperatures

February 24, 2021
The existing Emergency Use Authorization stipulates that the Pfizer/BioNTech vaccine must be stored in an ultra-cold freezer at temperatures between -112 to -76 Fahrenheit. Read More

EMA Reviewing Remdesivir for COVID-19 Patients Who Don’t Require Supplemental Oxygen

February 24, 2021
The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen. Read More

FDA Grants Sanofi’s Rare Hemophilia Drug Fast-Track Status

February 23, 2021
Efanesoctocog alfa previously received Orphan Drug designation from the FDA in August 2017 and from European regulators in June 2019. Read More
WHO

J&J Seeks WHO Emergency Use Listing for COVID-19 Vaccine

February 23, 2021
J&J submitted data from an ongoing global phase 3 trial, in which the vaccine showed 66 percent efficacy in preventing moderate-to-severe infection 28 days after inoculation. Read More

J&J Files for WHO Emergency Use Listing of Its COVID-19 Vaccine

February 22, 2021
Johnson & Johnson (J&J) has filed with the World Health Organization (WHO) for an Emergency Use Listing (EUL) for its COVID-19 vaccine — a listing that would clear the way for the vaccine to be distributed through the WHO’s COVAX vaccine-sharing program. Read More

Pfizer/BioNTech Seek FDA Approval to Raise COVID-19 Vaccine Holding Temperatures

February 22, 2021
Pfizer and BioNTech have filed for a revised Emergency Use Authorization (EUA) from the FDA to allow their COVID-19 vaccine to be stored at easier-to-accommodate freezer temperatures. Read More
Novartis building

Novartis’ Entresto Nabs FDA Approval for New Heart Failure Indication

February 19, 2021
The expanded indication notes benefits are most evident for patients whose left ventricular ejection fraction is below normal. Read More

Health Canada Clears Reblozyl for Myelodysplastic Syndromes

February 18, 2021
A phase 3 study found that 38 percent of patients receiving Reblozyl achieved transfusion independence for eight weeks or more at week 24. Read More

G1’s Cosela Approved for Treating Chemo-Induced Bone Marrow Suppression

February 18, 2021
The injectable drug is expected to become available in early March. Read More
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