Shots: The submissions are based on the P-II ELARA trial evaluates the efficacy and safety of Kymriah in adult patients with r/r FL after at least two prior therapies over […]readmore
Shots: The approval is based on the P-III GEMINI 1 & 2 studies to evaluate the efficacy, safety, and tolerability of Vuity vs PBO in a ratio (1:1) in 750 […]readmore
Shots: Health Canada has granted a NOC based on the P-II ZUMA-2 trial that evaluates Tecartus in 74 adult patients with r/r MCL who had previously received anthracycline or bendamustine […]readmore
Shots: The MAA is based on the P-III TRuE-V clinical program that consists of 2 P-III studies ie., TRuE-V1 & V2 evaluating ruxolitinib cream in 600+ patients aged ≥12yrs. with […]readmore
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
Shots: The approval is based on the P-III PEACHTREE trial to evaluate Xipere in 160 patients with macular edema associated with uveitis. The therapy is expected to be available in […]readmore
Shots: The submission is based on the P-III MOVe-OUT trial that evaluates molnupiravir (800mg, bid) in non-hospitalized adult patients with COVID-19 At the interim analysis, the therapy showed a ~50% […]readmore
Shots: The approval is based on P-III Archway study evaluates Susvimo (100 mg/mL, IV, q3mos.) via ocular implant vs ranibizumab (0.5mg, IV) in 415 patients with wet AMD prior responded […]readmore
Shots: The CDC’s ACIP has voted to recommend Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) to protect adults against invasive disease and pneumonia caused by the 20 S. pneumoniae serotypes The […]readmore
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The results showed a 65% avg. […]readmore