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RSS FeedPosted by Michael Wonder on 04 Apr 2018
US FDA approves Bydureon for use with basal insulin in patients with type 2 diabetes with inadequate glycemic control
3 April 2018 - Duration-7 study results showed significant HbA1c reduction when Bydureon was added to insulin glargine therapy vs insulin ...
Posted by Michael Wonder on 03 Apr 2018
Alkermes receives refusal to file letter from FDA for ALKS 5461
2 April 2018 - Alkermes today announced that it received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 29 Mar 2018
FDA expands approval of Blincyto for treatment of a type of leukaemia in patients who have a certain risk factor for relapse
29 March 2018 - The U.S. FDA granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor ...
Posted by Michael Wonder on 28 Mar 2018
FDA approves Toujeo Max SoloStar
27 March 2018 - Max SoloStar holds more insulin than any other long-acting insulin pen. ...
Posted by Michael Wonder on 27 Mar 2018
FDA authorises first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
27 March 2018 - The U.S. FDA today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for ...
Posted by Michael Wonder on 22 Mar 2018
Novartis drug Tasigna approved by FDA to treat children with rare form of leukaemia
22 March 2018 - New indication approved under FDA Priority Review designation; provides clinicians with paediatric-specific safety and clinical data. ...
Posted by Michael Wonder on 22 Mar 2018
FDA approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg pre-filled syringe for diabetic macular oedema and diabetic retinopathy
21 March 2018 - Pre-filled syringe options are now FDA-approved for all Lucentis indications. ...
Posted by Michael Wonder on 21 Mar 2018
Sun Pharma announces U.S. FDA approval of Ilumya (tildrakizumab-asmn) for the treatment of moderate-to-severe plaque psoriasis
21 March 2018 - Sun Pharmaceutical Industries today announced that the U.S. FDA has approved Ilumya (tildrakizumab-asmn) for the treatment of ...
Posted by Michael Wonder on 20 Mar 2018
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy
20 March 2018 - The U.S. FDA today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage ...
Posted by Michael Wonder on 18 Mar 2018
FDA approves Hizentra (immune globulin subcutaneous [human] 20% liquid) for the treatment of patients with chronic inflammatory demyelinating polyneuropathy
16 March 2018 - First and only subcutaneous immunoglobulin approved for the treatment of CIDP based on the largest controlled clinical ...
Posted by Michael Wonder on 12 Mar 2018
Hikma provides an update on the status of its ANDA for generic Advair Diskus
12 March 2018 - Hikma Pharmaceuticals announces that it is has received a response from the United States FDA in ...
Posted by Michael Wonder on 08 Mar 2018
23andMe granted first FDA authorisation for direct-to-consumer genetic test on cancer risk
6 March 2018 - Authorisation allows 23andMe to report on BRCA1- and BRCA2-related genetic risk for breast, ovarian and prostate cancer. ...
Posted by Michael Wonder on 07 Mar 2018
Sunovion receives FDA approval of supplemental new drug application for use of Latuda (lurasidone hydrochloride) in the treatment of bipolar depression in paediatric patients (10 to 17 years of age)
6 March 2018 - Sunovion Pharmaceuticals today announced that the U.S. FDA approved a supplemental new drug application that expands ...
Posted by Michael Wonder on 06 Mar 2018
FDA approves new HIV treatment for patients who have limited treatment options
6 March 2018 - Today, the U.S. FDA approved Trogarzo (ibalizumab-uiyk), a new type of anti-retroviral medication for adult patients living ...
Posted by Michael Wonder on 06 Mar 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) now the first and only FDA approved PD-1 inhibitor to offer every four week dosing
6 March 2018 - Opdivo also now approved for shorter 30-minute infusions, cutting previous infusion time in half ...