Blog
RSS FeedPosted by Michael Wonder on 20 Oct 2018
FDA approves label update for Genentech’s Rituxan (rituximab) in two rare forms of vasculitis
19 October 2018 - Rituxan label updated to include information for follow up treatment in adult patients with granulomatosis with polyangiitis ...
Posted by Michael Wonder on 20 Oct 2018
FDA approves asthma indication for Dupixent (dupilumab)
20 October 2018 - Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype. ...
Posted by Michael Wonder on 20 Oct 2018
FDA snubs Novartis bid to repurpose inflammation drug for heart attacks
19 October 2018 - The U.S. FDA has rejected Novartis’s bid to repurpose a drug now approved for rare inflammatory diseases ...
Posted by Michael Wonder on 17 Oct 2018
FDA approves Medicines360’s sNDA for Liletta (levonorgestrel-releasing intrauterine system) 52 mg to prevent pregnancy for up to five years
16 October 2018 - Allergan and Medicines360 announced that the U.S. FDA approved Medicines360’s supplemental new drug application to extend the ...
Posted by Michael Wonder on 16 Oct 2018
FDA approves Pfizer's drug for advanced breast cancer
16 October 2018 - The U.S. FDA said on Tuesday it approved Pfizer's drug for an advanced form of breast cancer ...
Posted by Michael Wonder on 15 Oct 2018
EyePoint Pharmaceuticals receives FDA approval of Yutiq (fluocinolone acetonide 0.18 mg intravitreal implant)
15 October 2018 - The first long-lasting, FDA approved micro-insert for up to three years of continuous control in chronic, non-infectious ...
Posted by Michael Wonder on 13 Oct 2018
FDA approves Stiolto Respimat supplemental new drug application to add data on COPD exacerbation reduction
11 October 2018 - Stiolto Respimat is the first in its class to have exacerbation data in the product labelling. ...
Posted by Michael Wonder on 12 Oct 2018
U.S. FDA approves Xarelto (rivaroxaban) to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease
11 October 2018 - This label expansion adds to six existing Xarelto indications granted since initial launch. ...
Posted by Michael Wonder on 11 Oct 2018
FDA approves new DNA-based test to determine blood compatibility
11 October 2018 - Test is first approved to report genotypes as final results. ...
Posted by Michael Wonder on 11 Oct 2018
FDA again approves record-breaking number of generic drugs
11 October 2018 - The FDA approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ...
Posted by Michael Wonder on 08 Oct 2018
Bausch Health's Bryhali (halobetasol propionate) 0.01% lotion receives tentative FDA approval for plaque psoriasis in adults
8 October 2018 - Company plans to launch Bryhali lotion in November 2018 upon final FDA approval. ...
Posted by Michael Wonder on 08 Oct 2018
Acacia Pharma provides update on FDA regulatory review of Barhemsys
8 October 2018 - FDA issued a complete response letter to Acacia Pharma on Friday 5 October. ...
Posted by Michael Wonder on 08 Oct 2018
FDA allows marketing of first self-fitting hearing aid controlled by the user
5 October 2018 - The U.S. FDA today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify ...
Posted by Michael Wonder on 08 Oct 2018
Valneva announces FDA approval of accelerated Ixiario vaccination schedule
5 October 2018 - Valneva announced today that the U.S. FDA has approved an alternate Ixiaro immunisation schedule of two doses ...
Posted by Michael Wonder on 06 Oct 2018
FDA approves Revcovi, a new enzyme replacement therapy developed by Leadiant Biosciences, for the treatment of ADA-SCID in paediatric and adult patients
5 October 2018 - Leadiant Biosciences today announced that the FDA has granted approval to Revcovi (elapegademase-lvlr) injection in the ...