FDA
New warning added to J&J vaccine in US
July 13, 2021Manufacturing and Production COVID-19, FDA, J&J, JJ, US, Vaccine
The FDA has made the decision to add a warning to the fact sheet for Johnson & Johnson’s COVID-19 vaccine, …
CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab
June 29, 2021Manufacturing and Production CHMP, EMA, EU, FDA, US
Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …
Eli Lilly to seek FDA approval for experimental Alzheimer’s drug
June 25, 2021Medical Communications Alzheimer's, Eli Lilly, FDA
Eli Lilly plans to seek accelerated FDA approval for its experimental Alzheimer’s drug donanemab, announcing plans on Thursday to file …
Moderna submits BLA with FDA for COVID vaccine
June 2, 2021Research 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 …
FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug
June 1, 2021Manufacturing 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 …
Asthma drug Dupixent sees positive results in child trials
May 18, 2021Manufacturing and Production FDA, asthma
Data presented at the 2021 American Thoracic Society International Conference from a Phase III trial of Dupixent (dupilumab) in children …
FDA authorizes use of Pfizer vaccine for children aged 12-15
May 11, 2021Manufacturing 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 …
Pfizer commences process for full FDA approval of COVID-19 vaccine
May 10, 2021Sales 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 …
Merck kidney and uterus cancer treatments granted priority review by FDA
May 7, 2021Medical 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 …
New HIV prevention drug application submitted to FDA
May 5, 2021Research 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 …
AstraZeneca drug approved by FDA for kidney disease treatment
May 4, 2021Manufacturing 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.
Takeda’s lung cancer drug granted FDA priority review
April 29, 2021FDA, 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 …
Calliditas’ kidney disease drug granted priority review by FDA
April 28, 2021Research 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 …
Lilly’s COVID-19 drug has EUA revoked in favour of combination therapy
April 19, 2021Sales 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 …
Gilead’s bladder cancer drug gets FDA approval
April 15, 2021FDA, 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).
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