Shots: The US FDA’s VRBPAC voted 17 to 0 with 1 abstention in favor of recommending the EUA for COVID-19 vaccine in children aged 5 to <12yrs. with COVID-19 The […]readmore
Tags : EUA
Shots: The P-III MOVe-OUT trial evaluates molnupiravir vs PBO in non-hospitalized adult patients with COVID-19 with 1 risk factor associated with poor disease outcomes & symptom onset within 5 days […]readmore
Shots: The submission is based on the P-III ENSEMBLE 2 study that evaluates the booster dose COVID-19 vaccine in adults aged ≥18yrs with COVID-19 The results demonstrated a 94% protection […]readmore
Shots: AstraZeneca has submitted a request to the US FDA seeking EUA for its AZD7442 to treatprophylaxis of symptomatic COVID-19. If EUA is granted, AZD7442 will be the first LAAB […]readmore
Shots: The US FDA has issued a EUA for the COVID-19 booster vaccine (administered at least 6mos. after completion of primary 2 doses) to prevent COVID-19 in individuals aged ≥65yrs. […]readmore
Shots: The DCGI has granted a EUA for ZyCoV-D which is the world’s first plasmid DNA vaccine for COVID-19. The company is planning to seek approval for the two-dose regimen […]readmore
Shots: The EUA is based on data from several clinical trials, including P-III trial evaluating REGEN-COV (SC injection or IV infusion) vs PBO in high-risk patients with COVID-19 for post-exposure […]readmore
Shots: The company has applied for emergency use authorization to the DCGI for ZyCoV-D, which is the world’s first plasmid DNA vaccine for COVID-19 Zydus conducted a clinical trial for […]readmore
COVID-19
Regulatory
Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s EUA for Hospitalized
Shots: The US FDA has issued a EUA for Actemra/RoActemra to treat COVID-19 in hospitalized adults & pediatric patients aged >2 yrs. who are receiving systemic corticosteroids & require supplemental […]readmore
Shots: The US FDA has granted EUA for sotrovimab for mild to mod. COVID-19 patients aged ≥12yrs. who are at high risk for progression to severe COVID-19 including hospitalization for […]readmore