Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2019
Priority review vouchers have helped to improve access to drugs targeting neglected diseases
22 April 2019 - The FDA priority review vouchers for neglected tropical diseases are aimed to incentivise pharmaceutical companies to ...
Posted by Michael Wonder on 23 Apr 2019
U.S. FDA accepts biologics license application for eptinezumab
22 April 2019 - Alder BioPharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license application for ...
Posted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...
Posted by Michael Wonder on 15 Apr 2019
Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD
15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab. ...
Posted by Michael Wonder on 11 Apr 2019
Cosmo Pharmaceuticals announces submission of remimazolam NDA TO FDA
9 April 2019 - Cosmo Pharmaceuticals today informed that the Remimazolam NDA has been submitted to FDA. ...
Posted by Michael Wonder on 07 Apr 2019
Celgene Corporation and Acceleron Pharma announce submission of luspatercept biologics license application to U.S. FDA
5 April 2019 - Submission includes both myelodysplastic syndromes and beta-thalassemia indications. ...
Posted by Michael Wonder on 07 Apr 2019
Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis
5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...
Posted by Michael Wonder on 07 Apr 2019
Kyowa Kirin announces FDA acceptance of istradefylline (KW-6002) new drug application resubmission in the US
4 April 2019 - Kyowa Hakko Kirin announced that the U.S. FDA has accepted for review the resubmitted new drug ...
Posted by Michael Wonder on 04 Apr 2019
Daiichi Sankyo provides update on ongoing FDA review for quizartinib for treatment of patients with relapsed/refractory FLT3-ITD AML
4 April 2019 - Daiichi Sankyo today announced that the U.S. FDA has extended the review period for the new ...
Posted by Michael Wonder on 04 Apr 2019
Ocular Therapeutix announces notification of FDA acceptance of supplemental new drug submission for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular inflammation following ophthalmic surgery
2 April 2019 - PDUFA target action date set for 10 November 2019 ...
Posted by Michael Wonder on 03 Apr 2019
Sandoz resubmits biosimilar pegfilgrastim application to US FDA
2 April 2019 - Sandoz pursues US approval for biosimilar pegfilgrastim, a long-acting version of supportive oncology medicine filgrastim. ...
Posted by Michael Wonder on 01 Apr 2019
Luye Pharma's Rykindo expected to be the first Chinese innovative drug to receive U.S. FDA approval
28 March 2019 - Luye Pharma Group has announced submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 01 Apr 2019
U.S. FDA acknowledges receipt of Intellipharmaceutics' resubmission of oxycodone ER new drug application, deems it a complete response, and designates 28 August 2019 as goal date for review
29 March 2019 - Intellipharmaceutics announced today that the U.S. FDA has acknowledged receipt of its resubmission of the Oxycodone ER ...
Posted by Michael Wonder on 29 Mar 2019
Janssen submits supplemental new drug application to U.S. FDA for Invokana (canagliflozin) for the treatment of chronic kidney disease in patients with type 2 diabetes mellitus
28 March 2019 - Submission is based on data from the landmark Phase 3 CREDENCE renal outcomes study, which stopped early ...
Posted by Michael Wonder on 29 Mar 2019
Amarin submits supplemental new drug application to U.S. FDA seeking new indication for Vascepa (icosapent ethyl) to reduce the risk of major adverse cardiovascular events based on landmark REDUCE-IT cardiovascular outcomes study
28 March 2019 - Amarin Corporation today announced that, as planned, it submitted a supplemental new drug application to the U.S. ...