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
JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies for moderate to severe atopic dermatitis
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
The notification implies that any export of Rapid Antigen Kit will require a licence or permission from DGFT
If approved it will bring a second source of MMR vaccine to the US market
Deal signed with AOP Orphan for US commercial rights
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