Shots: The approval is based on P-III HELP study results assessing Takhzyro (300 mg q2w, 300 mg q4w, 150 mg q4w) vs PBO in 125 patients with HAE aged ≥12 […]readmore
Tags : receives
Shots: The approval is based on the results of P-III PARADIGMS study assessing Gilenya (0.5mg/ 0.25mg, qd) vs Extavia (interferon beta-1a, qw) in 215 patients with MS aged 10 to […]readmore
Shots: The approval is based on the results of ongoing P-III ARRIVAL study assessing Kalydeco in patients who have either of 10 mutations in the CFTR gene (G551D, G178R, S549N, […]readmore
Shots: The approval is based on results of P-III ADMIRAL trial assessing Xospata (120 mg,qd ) vs salvage CT in ≥371 patients in ratio (2:1) with FLT3 mutations who are […]readmore
Shots: The approval is supported by PREVA (PREVention and Acute treatment of chronic cluster headache) and Real World retrospective study assessing its gammaCore + SoC vs SoC alone evaluating safety […]readmore
Biosimilars
Biotech
Celltrion’s Truxima (rituximab-abbs) Receives FDA’s Approval for Three on-Hodgkin’s Lymphoma
Shots: The approval is based on non-inferiority data demonstrating biosimilarity in pharmacology, immunogenicity, clinical efficacy with safety, potency and purity when compared to reference medicine (rituxan) Truxima is a mAb, […]readmore
Shots: The approval is based on the results of P-III DRIVE-AHEAD and DRIVE-FORWARD trial assessing Delstrigo vs efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) & Pifeltro vs darunavir + ritonavir (DRV+r) […]readmore
Shots: Accula RSV is second POC (point-of-care) test, to receive FDA’s 510(K) & CLIA Waiver and used additionally with nasal swab collection with disposable test cassettes The Accula RSV (respiratory […]readmore
Shots: The approval is based on combined data from P-I adult trial, P-II NAVIGATE trial and P-I/II pediatric SCOUT trial assessing Vitrakvi in solid tumors with neurotrophic receptor tyrosine kinase […]readmore
Shots: The approval is based on P-I & P-IV study assessing Actemra 162 mg SC via the pre-filled syringe (PFS) vs Actemra 162 mg SC via the ACTPen & testing […]readmore