HDT Bio receives Emergency Use Approval for Covid-19 vaccine in India
Gemcovac became the first saRNA vaccine to obtain approval for use in humans in India.
Approvals
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EC grants approval for Kite’s cell therapy to treat follicular lymphoma
The latest approval is based on findings from the Phase II ZUMA-5 trial in 122 relapsed or refractory FL patients.
Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults
The vaccine doses for Taiwan would be the first shipment to a nation participating in the COVAX Facility.
EC approves Novartis’ Tabrecta for non-small cell lung cancer
The EC approval is based on positive findings from the Phase II GEOMETRY mono-1 clinical trial of Tabrecta.
US FDA grants approval for Merck’s pneumococcal vaccine for children
The latest approval is based on findings from seven trials of the vaccine in infants, children and adolescents.
BioMarin’s Voxzogo obtains Japan’s MHLW approval for achondroplasia
In a Phase III trial, treatment with Voxzogo offered transient declines in blood pressure.
FDA grants EUA for Pfizer-BioNTech’s Covid-19 vaccine for children
The EUA is based on findings from a Phase II/III trial that comprised 4,526 children aged six months to four…
NICE recommends Hansa Biopharma’s imlifidase for kidney transplant patients
With the latest development, more than 100 individuals in England and Wales will be eligible to receive imlifidase.