Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a […]readmore
Tags : Older
Shots: The EC has granted MAA to Kaftrio (ivacaftor/tezacaftor/lumacaftor) + ivacaftor (150mg) to treat people with CF aged ≥12yrs. with one F508del mutation and one minimal function mutation (F/MF), or […]readmore
Regulatory
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Astellas’ VESIcare LS (solifenacin succinate) Receives the US FDA’s Approval
Shots: VESIcare LS is an oral suspension dosage prescribed medicine specifically developed to facilitate dosing and administration for children 2 years of age and older with a condition called neurogenic […]readmore
Shots: The approval is based on P-III study which involves assessing of leuprolide acetate (LA,45 mg) in 64 children with central (gonadotropin-dependent) precocious puberty evaluating its safety and pharmacokinetics The […]readmore
Shots: The sBLA submission is based on P-IIa PePRS study results assessing Rituxan (IV) + tapering course of oral glucocorticoids in 25 patients with severe GPA or MPA aged b/w […]readmore
Shots: The approval is based on P-III & P-I/II study results assessing Nplate vs PBO in pediatric patients with Immune Thrombocytopenia (ITP) for at least six months who had no response to corticosteroids, […]readmore
Shots: The approval is based on two study STICLO France and STICLO Italy assessing Diacomit vs PBO in patients with Dravet Syndrome aged 2 years of age and older taking […]readmore
Shots: The approval is based on three P-III studies results assessing Epidiolex (cannabidiol, PO) vs PBO in 516 patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome aged ≥ 2yrs. The study […]readmore