FDA declines to grant EUA for antidepressant to treat Covid-19
The data was inadequate to conclude that the drug was effective in preventing disease progression, FDA noted.
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FDA extends review period for Pfizer-Myovant’s sNDA for Myfembree
The regulatory agency needs additional time for reviewing further data on bone mineral density.
FDA limits usage of Janssen’s Covid-19 vaccine in adults
The FDA concluded that the thrombosis risk with thrombocytopenia syndrome warrants limited usage of the shot.
Novavax seeks expanded authorisation for Covid-19 vaccine in Great Britain
In paediatric expansion of PREVENT-19 trial, the vaccine offered an overall efficacy of 80%.
Moderna seeks expanded CMA in EU for Covid-19 vaccine in children
The authorisation is based on the positive interim findings from the Phase II/III KidCOVE clinical trial of the vaccine.
Pfizer and BioNTech seek FDA EUA for Covid-19 booster in children
In a Phase II/III trial, the booster vaccine offered a robust immune response in children aged five to 11 years.
EMA CHMP recommends Novartis’ Tabrecta for non-small cell lung cancer
The positive CHMP opinion is based on results from the Phase II GEOMETRY mono-1 trial of in Tabrecta in NSCLC…
NRx seeks breakthrough designation for Zyesami to treat Covid-19 patients
The latest filing comprises safety findings from nearly 750 patients who received intravenous Zyesami for critical Covid-19.