Shots: The approval is based on two clinical studies and a retrospective analysis of RWD. The device is intended to be used by prescription only as an adjunct to a […]readmore
Tags : approval
Shots: EMA’s CHMP has adopted a positive opinion recommending the use of Benlysta (IV, SC) in combination with background immunosuppressive therapies for the treatment of adult patients with active LN […]readmore
Shots: The approval is based on the P-II KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent, a […]readmore
Shots: The FDA has approved Myrbetriq (ER tablets) for NDO in children aged ≥3yrs. who weigh ≥35kg and Myrbetriq Granules (ER oral suspension) for NDO in pe children aged 3yrs. […]readmore
Shots: The MHLW has approved Acuvue Theravision with Ketotifen as the first combination contact lens that provides vision correction and an antihistamine drug to relieve symptoms for people experiencing itchy […]readmore
Shots: The approval is based on results from P- Ib/II GO29365 study assessing Polivy (IV, 30 & 140mg) + BR vs BR alone in 80 DLBCL patients and P-II JO40762/P-DRIVE […]readmore
Shots: The approval is based on the P-II FIGHT-202 study that involves assessing Pemazyre (13.5mg, qd, on a 21-day cycle) in adults aged ≥18yrs. with previously treated, LA/m- cholangiocarcinoma with […]readmore
Shots: The approval is based on efficacy results from P-III studies involve assessing Zegalogue vs PBO in children aged 6-17yrs. and in adults with T1D The study met its 1EPs […]readmore
Shots: The approval is based on the P-III head-to-head OPTIMUM trial involves assessing Ponvory (20 mg) vs Teriflunomide (14 mg) in adults with relapsing MS and follows >10 yrs of […]readmore
Shots: The US FDA has approved the IND application of HLX04-O for the treatment of wAMD The P-III clinical study of HLX04-O will be conducted to further evaluate the efficacy […]readmore