Drug Approval | July 13, 2025
Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
Xtandi is approved in over 80 countries, including the U.S., EU, and Japan
Additional data will be presented on a once-weekly oral combination of islatravir and ulonivirine (ISL/ULO) for HIV-1 treatment
India’s fertility rate has dropped to 1.9, below the replacement level of 2.1
CSIR-IGIB advances indigenous CRISPR Trials on sickle cell anaemia, anti-microbial resistance, liver fibrosis and rare disorders
Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
Treatment with XPro was well-tolerated and safe, even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients
Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
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