Shots: The company reported the voluntary withdrawal of the Tecentriq (atezolizumab) indication in the US for prior-platinum treated mUC, bladder cancer The withdrawal was made in consultation with the US […]readmore
Tags : Indication
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
Shots: The approval of additional indication is based on a P-lll study involve the assessing the efficacy and safety of Humira targeting the patients with active ulcers in Japan who […]readmore
Shots: The designation is based on P-III PROTECTIVE-2 evaluating Plinabulin + Neulasta vs Neulasta alone for the treatment of CIN In the protocol-specified interim analysis, combination regimen was better than […]readmore
Shots: The approval follows P-III ACE study assessing chidamide + exemestane demonstrated PFS benefit and the includes Chidamide + aromatase inhibitor in postmenopausal patients with HR+, HER2- advanced breast cancer […]readmore
Shots: The approval is based on a P-III study results assessing Eticovo vs the reference product (Enbrel) in 596 patients with rheumatoid arthritis across 70 sites in 10 countries The […]readmore
Shots: The approval is based on COAPT study assessing MitraClip + medical therapy vs medical therapy as monothx. in 614 patients with moderate to severe secondary MR across 78sites including […]readmore
MedTech
Regulatory
Medtronic Resolute Drug-Eluting Stent (DES) Platform Receives FDA’s Approval for
Shots: The expanded indication approval is based on PERSPECTIVE Study assessing 183 patients with older-generation Resolute Integrity DES The study resulted in low rates of repeat revascularization 1.1%, cardiac death […]readmore
Regulatory
Medtronic’s Pipeline Flex Embolization Device Receives FDA’s Expanded Indication Approval
Shots: The expanded approval is based on PREMIER Trial assessing Pipeline Flex in 141 patients with mean aneurysm size of 5.0±1.92 mm The study resulted in one-year occlusion rates of […]readmore
Shots: The expanded approval is based on P-II BLAST study results assessing Blincyto (15ug/m2/d @4wks.) in patients with 3L + MRD-positive ALL in complete hematologic remission, evaluating its efficacy, safety, […]readmore