Shots: The approval is based on the P-III RHAPSODY trial involves assessing Arcalyst (SC, qw, 300mg followed by 160mg) vs PBO in adults and children aged ≥12yrs. in a ratio […]readmore
Tags : approval
Shots: The approval is based on P-III SOLO trial involves assessing the safety, efficacy, and PK of Kimyrsa (qd, 1200 mg, IV dose, over 1 hour) vs vancomycin (1gm or […]readmore
Shots: The approval is based on a P-III TIVO-3 study that involves assessing Fotivda (1.34 mg/qd, with or without food for 21days followed by 7days off treatment) vs sorafenib in […]readmore
Shots: The US FDA has granted approval of Ventana ALK (D5F3) as a CDx assay to identify ALK+ NSCLC patients eligible for treatment with Pfizer’s drug Lorbrena (lorlatinib) The label […]readmore
Shots: The approval is based on a P-II ZUMA-5 study assessing Yescarta (axicabtagene ciloleucel) in 146 patients aged ≥18rs. with r/r iNHL, prior treated with at least 2L of systemic […]readmore
Shots: The approval is based on P-III focuSSced trial assessing Actemra (SC, 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The data from P-I/II fascinate study […]readmore
Shots: The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC The P-III […]readmore
Regulatory
Corium’s Azstarys (serdexmethylphenidate and dexmethylphenidate) Receives the US FDA’s Approval
Shots: The approval is based on a P-III study that involves assessing Azstarys (qd) vs PBO in 150 children aged 6-12yrs. with ADHD The study showed improvement in 1EPs i.e. […]readmore
Regulatory
BeiGene’s Brukinsa (zanubrutinib) Receives Health Canada’s Approval for Waldenström’s Macroglobulinemia
Shots: The approval is based on a P-III APSEN study involve assessing Brukinsa vs ibrutinib in 201 patients with r/r or TN WM who harbor an MYD88 mutation (MYD88MUT). The […]readmore
Shots: On Feb 12, 2021, the US FDA has approved Cosela to decrease the incidence of CT induced myelosuppression in adult patients when administered before a platinum/etoposide-containing regimen or topotecan-containing […]readmore