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Showing 15 posts of 1442 posts found.

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Moderna submits BLA with FDA for COVID vaccine

June 2, 2021
Research and Development COVID-19, EU, FDA, Lonza, Moderna, production

Moderna has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of …

News

FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug

June 1, 2021
Manufacturing and Production EMA, FDA, FOP, NDA, ipsen

The FDA have accepted Ipsen’s New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention …

News
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Asthma drug Dupixent sees positive results in child trials

May 18, 2021
Manufacturing and Production FDA, asthma

Data presented at the 2021 American Thoracic Society International Conference from a Phase III trial of Dupixent (dupilumab) in children …

News
pfizer

FDA authorizes use of Pfizer vaccine for children aged 12-15

May 11, 2021
Manufacturing and Production COVID-19, FDA, Pfizer, Vaccine

The FDA announced it has expanded the emergency use of the Pfizer-BioNTech vaccine in children aged 12-15 yesterday.It was determined …

News
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Pfizer commences process for full FDA approval of COVID-19 vaccine

May 10, 2021
Sales and Marketing BioNTech, COVID-19 vaccine, FDA, Pfizer, Pfizer vaccine, pharma, pharma news

Pfizer and BioNTech have begun a Biologics Licence Application (BLA) with the FDA for full approval of their mRNA COVID-19 …

News

Merck kidney and uterus cancer treatments granted priority review by FDA

May 7, 2021
Medical Communications FDA, MSD, Merck, cancer treatment, kidney cancer treatment, pharma, pharma news, uterus cancer treatment

The FDA has granted priority review for Merck (MSD) and Eisai’s application for two new approvals for the combination of …

News

New HIV prevention drug application submitted to FDA

May 5, 2021
Research and Development FDA, HIV

ViiV Healthcare have initiated a rolling submission of a new drug application (NDA) with the FDA for their long-acting HIV …

News

AstraZeneca drug approved by FDA for kidney disease treatment

May 4, 2021
Manufacturing and Production AstraZeneca, FDA, kidney disease, pharma, pharma news

AstraZeneca’s Farxiga drug has been approved for the treatment of chronic kidney disease (CKD) in the US by the FDA.

News
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Takeda’s lung cancer drug granted FDA priority review

April 29, 2021
FDA, Takeda, lung cancer treatment, pharma, pharma news

The FDA has granted priority review for Takeda’s New Drug Application (NDA) for its mobocertinib drug for the treatment of …

News

Calliditas’ kidney disease drug granted priority review by FDA

April 28, 2021
Research and Development Calliditas, FDA, nephropathy, pharma, pharma news

The FDA has granted priority review for the New Drug Applicaton (NDA) for Calliditas Therapeutics’ Nefecon, for the treatment of …

News
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Lilly’s COVID-19 drug has EUA revoked in favour of combination therapy

April 19, 2021
Sales and Marketing COVID-19, Eli Lilly, FDA, covid-19 treatment, lilly, pharma, pharma news

The FDA have revoked Emergency Use Authorization (EUA) of Eli Lilly’s bamlanivimab drug for the treatment of COVID-19, per the …

News
Gilead sign

Gilead’s bladder cancer drug gets FDA approval

April 15, 2021
FDA, Gilead, bladder cancer, bladder cancer treatment, pharma, pharma news

The FDA have granted accelerated approval to Gilead’s Trodelvy drug for the treatment of metastatic urothelial cancer (UC).

News

J&J vaccine halted in US due to blood clots

April 14, 2021
Research and Development CDC, COVID-19 vaccine, FDA, Janssen, Johnson & Johnson, pharma, pharma news

The CDC and FDA have recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine in the …

News

Akari Therapeutics open IND with FDA for bullous pemphigoid treatment

April 13, 2021
Manufacturing and Production FDA

Akari Therapeutics have opened an investigational new drug application (IND) with the FDA for its multicentre Phase III study with …

News

Immutep achieves FDA Fast Track designation for soluble LAG-3 protein

April 12, 2021
Sales and Marketing FDA, HNSCC

Immutep, a biotechnology company developing novel immunotherapy treatments for cancer, infectious disease, and autoimmune disease, has achieved FDA Fast Track …

News
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