FDA grants Fast Track designation to COVID-19 ARDS treatment
The designation should expedite the review of remestemcel-L, a cellular therapy that has shown promise in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients.
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The designation should expedite the review of remestemcel-L, a cellular therapy that has shown promise in treating acute respiratory distress syndrome (ARDS) in COVID-19 patients.
The first patient with bronchiectasis has been dosed in the Phase III ASPEN study of brensocatib, a reversible inhibitor of dipeptidyl peptidase 1.
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
Dr Ash Ramzan, founder and principal consultant at Woodley BioReg, discusses how the COVID-19 pandemic has forced regulatory processes to adapt, focusing on the regulatory flexibilities introduced by the UK’s MHRA.
The designation should expedite the development and review of AB201, a recombinant protein therapy being tested in hospitalised COVID-19 patients.
Researchers have shown that recipients of the Bacillus Calmette-Guérin (BCG) vaccine are less likely to contract COVID-19 in a new study.
A single-use, self-administered microneedle vaccine has been developed to provide immunisation against infectious diseases.
PhRMA and other organisations have challenged action by the HHS and FDA that permits the importation of drugs from Canada without drug manufacturers’ oversight.
Zokinvy (lonafarnib) capsules have been approved for the treatment of Hutchinson-Gilford progeria syndrome and certain progeroid laminopathies in patients over one year old.
The Emergency Use Authorization (EUA) is based on a trial in which casirivimab and imdevimab reduced hospitalisations in mild to moderate COVID-19 patients.
Both the UK and US have said that, if approved, the Pfizer and BioNTech COVID-19 vaccine could be administered to people as early as December.
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
Ibezapolstat cured all 10 patients of their Clostridioides difficile infections and prevented recurrence for at least 30 days.
The FDA has issued an Emergency Use Authorization for baricitinib in combination with remdesivir to treat COVID-19 in hospitalised patients.
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.