Add this result to my export selection FDA grants approval of trilaciclib (Cosela) as adjunct preceding first line chemotherapy for small cell lung cancer Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 12 February 2021 Trilaciclib is a 1st-in-class short-acting CDK4/6 inhibitor which preserves hematopoietic stem cells and enhances immune system function during chemotherapy. Approval was based on three RCTs (n=245) ... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection FDA Drug Safety Communication: Initial safety trial results find increased risk of serious heart-related problems and cancer with tofacitinib Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 04 February 2021 The initial results of a completed safety clinical trial show a higher occurrence of serious heart-related problems and cancer in patients with rheumatoid arthritis treated with tofacitinib (both 5mg... Read Summary SPS comment Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection FDA issues emergency use authorization for single dose Janssen COVID-19 Vaccine Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 27 January 2021 Approval was based on analysis of 39,321 subjects from an ongoing global placebo-controlled RCT (n= 43,783) which found the vaccine was 67% and 66% effective in preventing moderate to severe/critical... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection FDA approves more flexible storage and transportation conditions for Pfizer-BioNTech COVID-19 vaccine Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 25 February 2021 Following the submission of supporting data from Pfizer, the US FDA is now permitting undiluted frozen vials of its Covid-19 vaccine to be transported and stored at conventional temperatures commonly... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection US FDA approves casimersen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 25 February 2021 The approval, the first of a targeted treatment for patients with this type of mutation, was based on a placebo-controlled study (n=43) which found those treated with casimersen had a significantly... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection US FDA approves revisions to Triumeq (abacavir/dolutegravir/lamivudine) and Dovato (dolutegravir/lamivudine) prescribing information Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 11 March 2021 The approved revisions include dosing in patients with creatinine clearance of 30-49 mL per min. These patients may experience a 1.6- to 3.3-fold higher lamivudine exposure and they should be... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection FDA grants approval of idecabtagene vicleucel for treatment of adults with relapsed/refractory multiple myeloma Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 27 March 2021 Approval of this first in class B-cell maturation antigen therapy is based on a study of 127 pts who received at least three prior lines of therapy. The overall response rate was 72% and 28% achieved... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection US FDA approves Myrbetriq (extended-release mirabegron) for treatment of neurogenic detrusor overactivity in children ≥3 years Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 25 March 2021 Efficacy of Myrbetriq and Myrbetriq Granules for this indication was established in a study of 86 patients aged 3-17, in which treatment was associated improvements in a number of endpoints, ... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection FDA grants license extension of alirocumab (Praluent) as an adjunct for treatment of adults with homozygous familial hypercholesterolaemia Source: US Food and Drug Administration - FDA (Remove filter) Published by US Food and Drug Administration, 04 April 2021 Approval was based on a 12-week RCT which demonstrated a 27% decrease in LDL-C from baseline in the 45?patients treated with alirocumab, in addition to other lipid lowering therapies, vs a 9% ... Read Summary Type: Medicines Current Awareness (Remove filter)