News | October 11, 2021
Merck and Ridgeback seek EUA from U.S. FDA for molnupiravir
If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19
If authorized, molnupiravir could be the first oral antiviral medicine for the treatment of Covid-19
The rolling submission to the U.S. FDA will begin in the fourth quarter of this year
The applicants will only have to get their Good Manufacturing Practices certification validated every five years to retain their licence
It is a recombinant nanoparticle protein-based vaccine
CuraTeQ Biologics is on track for filing a second oncology biosimilar
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
In the final analysis of Phase 3 COVE study data, SPIKEVAX showed 93% efficacy, with the efficacy remaining durable through six months after the administration of the second dose
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
First launched in 2005, pharmaREADY is a fully integrated, regulatory compliant, web-based platform to create, view, and manage global regulatory submissions
Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in the early calendar year 2022
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