Shots: The CHMP (EMA) recommendation is based on P-II CA180-372 (NCT01460160) study assessing Sprycel + CT in pediatric patients with newly diagnosed +ve acute lymphoblastic leukemia (ALL) Sprycel received the US FDA’s and EU’s […]readmore
Shots: The approval is based on P-III EORTC1325/KEYNOTE-054 trial assessing Keytruda (IV 200mg, q3w) as adjuvant therapy vs PBO, in 1,019 patients in ratio (1:1) with completely resected melanoma (stage IIIA [>1 mm […]readmore
Shots: The approval is based on six trials assessing Motegrity vs PBO in 2,484 patients with Chronic Idiopathic Constipation (CIC) in adults P-III study results: normalization of BM frequency (19-38% […]readmore
Shots: The approval is based on P-III & P-I/II study results assessing Nplate vs PBO in pediatric patients with Immune Thrombocytopenia (ITP) for at least six months who had no response to corticosteroids, […]readmore
Shots: The approval is based on non-inferiority data assessing Herzuma vs Herceptin (trastuzumab), testing its safety, efficacy, PK &PD, and immunogenicity The study demonstrated with bio-similarity in terms of purity, […]readmore
Shots: The approval is based on trial results assessing Xolair IV (q2w or q4w) in 1M patients with SAA and CSU for 13 years The study demonstrated in reduction of severe exacerbations, corticosteroid […]readmore
Shots: The approval is based on P-III study results assessing Orkambi in 60 patients with CF, who have two copies of the F508del CFTR mutation aged 6 to 11 years for 24 wks. […]readmore
Shots: The approval is based on trial results assessing reSET-O in 170 patients receiving either treatment-as-usual (TAU) + standard clinician interactions + buprenorphine or reSET-O + standard clinician interactions + […]readmore
Shots: The approval is based on P-III IMpower150 study results assessing Tecentriq + CT (paclitaxel & carboplatin) + Avastin (bevacizumab) (w or w/o) in 1202 patients in ratio (1:1:1) with […]readmore
Shots: The approval is based on three P-III study (104,111 & 109) results assessing Genvoya (elvitegravir/ cobicistat /emtricitabine /tenofovir alafenamide /150 / 150/ 200/ 10mg, E/C/F/TAF) vs Stribild (E/C/F/TDF,150 mg/ […]readmore
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