Shots: The approval is based on non-inferiority data demonstrating biosimilarity between Retacrit and the reference product, Epogen & Procrit In May, 2016 Pfizer and Vifor Pharma collaborated for the commercialization […]readmore
Shots: The approval is based on two clinical studies results assessing Akynzeo (NEPA) vs Palonosetron in patients with CINV across 80 centers in 11 countries The two clinical studies Trial […]readmore
Shots: The FDA’s BT designation is based on P-III HAVEN 3 study assessing Hemlibra vs no prophylaxis in 152 patients in ratio (2:2:1) with hemophilia A + prior treated with […]readmore
Shots: The approval is based on CHMP (EMA) recommendation, reviewed by EU for diabetic patients In 2009, Mylan and Biocon globally collaborated to jointly develop multiple generic biologic compounds Semglee […]readmore
Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, […]readmore
Shots: The FDA’s BT designation is based on P-II study results assessing PTI-428 (50 mg, qd) vs PBO in 24 CF with F508del mutation on background treatment with Orkambi for […]readmore
Shots: The approval is based on three FIT studies results assessing Tavalisse (100/150mg, bid) vs Placebo in 150 patients with chronic ITP in ratio 2:1 The FIT studies result: FIT-1 […]readmore
Shots: The approval is based on clinical study results assessing Trogarzo (ibalizumab, IV) in 40 patients with MDR-HIV The study resulted in depletion of HIV-RNA level in blood in 43% […]readmore
Shots: The approval is based on positive opinion by CHMP (EMA) assessing Herzuma and reference trastuzumab in patients with HER2 overexpression/gene amplification tumors in breast cancer, metastatic breast cancer and […]readmore
Shots: The approval is based on P-III SPARTAN study results assessing Erleada (240 mg,qd) vs PBO in 1,207 patients with NM-CRPC in ratio (2:1) in patients with (NM-CRPC) P-III SPARTAN […]readmore
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