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
Shots: The FDA’s BT Designation is based on P-II study assessing SAGE-217 vs PBO in 89 patients with moderate to severe major depressive disorder (MDD) The P-II study results: met […]readmore
Shots: The US FDA grants BT designation to Promacta (eltrombopag) + standard immunosuppressive therapy (SIT) for patients with 1L severe aplastic anemia (SAA) The BT designation is based on research […]readmore
Shots: The FDA’s BT designation is based on P-III MONALEESA-7 study assessing Kisqali + tamoxifen/ aromatase inhibitor + goserelin vs tamoxifen/aromatase inhibitor + goserelin in 672 pre/perimenopausal women with HR+/HER2- […]readmore