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RSS FeedPosted 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 27 Mar 2018
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for previously treated patients with MSI-H or dMMR metastatic colorectal cancer for priority review
27 March 2018 - The FDA also granted the Opdivo plus Yervoy combination breakthrough therapy designation for this potential indication. ...
Posted by Michael Wonder on 27 Mar 2018
Lexicon Pharmaceuticals announces regulatory submissions for sotagliflozin to treat adults with type 1 diabetes
26 March 2018 - New drug application submitted to U.S. FDA and marketing authorisation application submitted to EMA. ...
Posted by Michael Wonder on 27 Mar 2018
Palatin Technologies announces submission of bremelanotide NDA to FDA for treatment of hypoactive sexual desire disorder in premenopausal women
26 March 2018 - Palatin Technologies announced today that its exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals, has submitted a ...
Posted by Michael Wonder on 27 Mar 2018
Bayer announces completion of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancer
26 March 2018 - Bayer today announced that its collaboration partner Loxo Oncology has completed the rolling submission of a new ...
Posted by Michael Wonder on 26 Mar 2018
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for enfortumab vedotin in locally advanced or metastatic urothelial cancer
26 March 2018 - Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 23 Mar 2018
Progenics Pharmaceuticals announces three month extension of PDUFA date for Azedra (iobenguane I 131)
22 March 2018 - Progenics Pharmaceuticals announced today that the Company has received notification from the U.S. FDA that the ...
Posted by Michael Wonder on 22 Mar 2018
House approves ‘right-to-try’ bill giving seriously ill patients access to experimental drugs
22 March 2018 - The House approved “right-to-try” legislation on Wednesday that would bypass drug regulators and give critically ill ...
Posted by Michael Wonder on 22 Mar 2018
FDA wants to help unproductive drug makers
22 March 2018 - America’s pharmaceutical giants may also need to rethink their business model. ...
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
Fennec Pharmaceuticals receives fast track designation by FDA for Pedmark
21 March 2018 - Fennec Pharmaceuticals today announced that the U.S. FDA has granted Pedmark (a unique formulation of sodium thiosulfate) ...
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, industry ponder changes to clinical trials for rare disease treatments
19 March 2018 - FDA statisticians pondered changing how the agency uses statistics to approve drugs for rare disease at ...