Shots: First and only therapy approved for LD patients with confirmed or acquired in adults and children ≥2yrs; partial or acquired LD in adults or children ≥12yrs in Europe after […]readmore
Tags : receives
Shots: The approval is based on two study STICLO France and STICLO Italy assessing Diacomit vs PBO in patients with Dravet Syndrome aged 2 years of age and older taking […]readmore
Shots: EU has approved intake of Xeljanz 10mg BID for 8 weeks followed by 5mg or 10mg for moderate to active UC in adults Xeljanz is now approved in […]readmore
Shots: Mulpleta is approved based on two randomized, placebo-controlled trials (L-PLUS 1 & 2) involving 312 patients with platelets ≤50 x 109/L randomized 1:1 to receive 3mg once upto 7 […]readmore
Biosimilars
Pharma
Pfizer receives EU approval for Trazimera(Trastuzumab), the First Oncology Biosimilar
Shots: Trazimera is a biosimilar of Herceptin indicated for treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma The EC approval is based on the data […]readmore
Shots: AZEDRA radio therapeutic indicated to treat adult and pediatric patients ≥12yrs with iobenguane scan positive Has shown reduction rate in need of blood pressure medication and tumor size in […]readmore
Shots: Imfinzi has been approved in unresectable PD-L1 expressing LA NSCLC patients treated with platinum-based CRT Approval is based post-hoc subgroup analyses by PD-L1 expression in addition to PFS & OS […]readmore
Shots: The approval is based on non-inferiority data assessing Hyrimoz vs reference biologic in patients with rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis and ulcerative colitis The study demonstrated in […]readmore
Shots: The approval is based on P-I AG120-C-011 (NCT02074839) study results assessing Tibsovo (ivosidenib, 500mg) in 174 patients with r/r AML and IDH1 mutation aged 67 yrs. P-I AG120-C-011 study […]readmore
Shots: The approval is based on Detective Part 1 & Part 2 (TAF112582) and Gather (TAF116564) studies results assessing Krintafel (tafenoquine, 300mg) in 800 patients with relapse P.vivax malaria The […]readmore