GSK’s Nucala (mepolizumab) Receives the EC’s Approval for the Treatment of Eosinophil-Driven Diseases
Shots: The approvals are based on the clinical trials to evaluate mepolizumab vs PBO when added to SoC in patients with HES, EGPA & CRSwNP […]
Shots: The approvals are based on the clinical trials to evaluate mepolizumab vs PBO when added to SoC in patients with HES, EGPA & CRSwNP […]
Shots: The approval is based on the data from PK bridging studies and P-III EVOLVE-MS-2 study to evaluate the GI tolerability of Vumerity vs Tecfidera […]
Shots: The EC has granted marketing authorisation for Celltrion’s regdanvimab in adults with COVID-19 who do not require supplemental oxygen & are at high risk […]
Shots: The approval is based on the P-III trial that evaluates Ultomiris (q4w/q8w) vs Soliris in children & adolescents aged ≤18yrs. with PNH The interim […]
Shots: The conditional approval is based on the P-II L-MIND study evaluating the safety and efficacy of tafasitamab + lenalidomide in patients with r/r DLBCL […]
Shots: The approval is based on 3 P-III studies i.e., Measure Up 1/2/AD Up evaluating the efficacy & safety of Rinvoq (15/30 mg, qd) as […]
Shots: The approval is based on 3 P-III studies i.e., BE VIVID, BE READY, BE SURE evaluating the efficacy & safety of bimekizumab vs PBO […]
Shots: The conditional approval is based on KarMMa study evaluating Abecma (single infusion with a target dose of 420 x 106 CAR T cells) in […]
Shots: The approval is based on safety & efficacy data from the P-III LIBERTY program that consists of 2 studies i.e LIBERTY 1 & 2 […]
Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed […]
Shots: The MAA is based on a P-III BLISS-LN study assessing the efficacy and safety of belimumab (10 mg/kg, IV) + standard therapy vs PBO […]
Shots: The EC has granted conditional approval for Jemperli in women with dMMR/ MSI-H endometrial cancer that has progressed on or following prior treatment with […]
Shots: The approval is based on P-III study evaluating cannabidiol (25 mg/kg/day) vs PBO in patients aged ≥2yrs. as an adjunctive treatment of seizures associated […]
Shots: The approval is based on data from the P-III IKEMA study evaluating Sarclisa + carfilzomib and dexamethasone (Kd) vs Kd alone in 302 patients […]
Shots: The approval is based on P-III CheckMate -9ER trial involves assessing Opdivo + Cabometyx vs sunitinib in 651 patients with previously untreated advanced or […]
Shots: The EC has granted ODD for PBKR03 for the treatment of Krabbe disease. The ODD was based on an EMA’s COMP positive opinion The […]
Shots: The EC has approved MB02 biosimilar to Avastin (Bevacizumab) in the EU for the treatment of carcinoma of the colon or rectum, BC, NSCLC, […]
Shots: The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, PO, qd) in […]
Shots: The EC approval follows CHMP’s positive recommendation for Yuflyma (high concentration formulation) granted in Dec’2020. The approval covers all 13 intended indications to treat […]
Shots: The EC approval follows CHMP’s positive recommendation for Kixelle to treat DM in adults, adolescents, and children aged ≥1yr. The biosimilar has been approved […]
Shots: The EC granted ODD for VO659 for the treatment of spinocerebellar ataxia (SCA). The ODD was based on a EMA’s COMP positive opinion The […]
Shots: The EC approval is based on JAKARTA and JAKARTA2 studies. The pivotal JAKARTA study involves assessing Inrebic (500mg) vs PBO in 289 patients with […]
Shots: The approval is based on data from three pivotal clinical trials P-II SELECT-PsA 1& 2 and P-II/III SELECT-AXIS 1 involves assessing of Rinvoq in […]
Shots: The approval is based on pivotal P-III KEYNOTE-177 study involves assessing of Keytruda (200mg, q3w) vs CT regimen in 307 patients in a ratio […]
Shots: The EC has approved Xofluza (baloxavir marboxil) for uncomplicated influenza in patients aged≥12yrs. Additionally, the EC has approved Xofluza for post-exposure prophylaxis of influenza […]
Shots: The approval is based on P-ll/lll study involve the assessment of Comirnaty (BNT162b2) vs PBO in 44,000 patients aged ≥16 yrs. in the ratio […]
Shots: The EC has granted MAA to Kaftrio (ivacaftor/tezacaftor/lumacaftor) + ivacaftor (150mg) to treat people with CF aged ≥12yrs. with one F508del mutation and one […]
1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, […]
Shots: The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine […]
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective […]
Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & 161 people […]
Copyright © 2024 | WordPress Theme by MH Themes