Shots: The ODD follows P-I/II study assessing TLC178 in patients with advanced malignancies in adults and has resulted in no dose-limiting toxicity till date The EMA’s Orphan Drug Designation (ODD) […]readmore
Tags : receives
Shots: Post EMA’s ODD, A4250 has received FDA’s ODD following its P-III study assessing A4250 in patients with Alagille syndrome, biliary atresia and primary biliary cholangitis (PBC) FDA has granted […]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
Shots: The Study Watch has received FDA’s 510 (k) Clearance as a Class II medical device for its on-demand ECG feature The medical device is used for displaying single-channel ECG […]readmore
Biosimilars
Biotech
Sandoz’s Erelzi (etanercept, biosimilar) Receives Health Canada Approval for Psoriatic
Shots: The approval is based on P-III EGALITY study results assessing Erelzi (etanercept) vs Enbrel, evaluating its PK, safety and efficacy On 17 Jan, 2019 Sandoz received NOC from Health […]readmore
Biosimilars
Biotech
Regulatory
Amgen and Allergan’s Mvasi (bevacizumab, biosimilar) + Combination Therapy Receives
Shots: The approval is based on P-III study results assessing Mvasi vs bevacizumab in patients with non-squamous NSCLC The study demonstrated in biosimilarity of Mvasi with bevacizumab in terms of […]readmore
Shots: The approval is based on P-III study results assessing Linzess (290 mcg) vs PBO in 839 patients in ratio the (1:1) with IBS-C in adults for 12 weeks The […]readmore
Shots: The BT designation follows the P-II trial assessing Zanubrutinib in patients with 1L mantle cell lymphoma Beigene’s Zanubrutinib is being evaluated globally in seven P-III trials in multiple areas […]readmore
Shots: The approval is based on ADO II AS study results assessing the Amplatzer Piccolo in 50 patients with PDA older than three days across eight centers in the US, […]readmore
Regulatory
Exelixis’ Cabometyx (cabozantinib) Receives FDA Approval for Previously Treated Hepatocellular
Shots: The approval is based on P-III CELESTIAL study results assessing Cabometyx (60 mg, qd) vs PBO in 760 patients in a ratio (2:1) with 2L advanced HCC who previously […]readmore