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Home » Topics » Pharmaceuticals » Submissions and Approvals

Submissions and Approvals
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FDA Grants Exicure’s Merkel Cell Carcinoma Treatment Orphan Drug Designation

March 8, 2021
If approved, cavrotolimod will qualify for seven years of market exclusivity. Read More

UK’s NICE Recommends Eli Lilly’s Olumiant for Eczema

March 5, 2021
Lilly has agreed to provide the drug to the UK’s National Health Service at a discounted price. Read More

KemPharm’s Azstarys Secures FDA Approval for ADHD

March 5, 2021
Azstarys is expected to become commercially available in the U.S. in the second half of 2021. Read More

FDA Accepts Merck’s NDA for Chronic Cough Medication

March 3, 2021
Gefapixant would become the first drug approved specifically for the indications if the drug ends up earning the FDA’s blessing, Merck said. Read More
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BridgeBio Pharma’s, Origin Biosciences’ Nulibry Nabs FDA Approval for Fatal Rare Genetic Metabolism Disorder

March 3, 2021
Administered intravenously, Nulibry works by replacing a missing substance in patients called cyclic pyranopterin monophosphate. Read More
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Sarepta Therapeutics Wins FDA Approval for Duchenne Muscular Dystrophy Injection

March 2, 2021
The FDA approved Amondys 45 based on an increase in dystrophin production in skeletal muscle observed in patients treated with the therapy. Read More
Pfizer logo new 2021

Pfizer Receives OK From FDA to Raise Its Vaccine Storage Temperature

March 1, 2021
The newly approved temperature specifications would not require Pfizer to ship and store the vaccine in specially designed containers. Read More

FDA Approves Pfizer’s Request to Raise Vaccine Storage Temperature

February 26, 2021
The FDA has approved Pfizer’s and BioNTech’s request for a revised Emergency Use Authorization (EUA) permitting their COVID-19 vaccine to be stored at normal pharmaceutical freezer temperatures. Read More

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
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