Blog
RSS FeedPosted by Michael Wonder on 01 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb announce U.S. FDA breakthrough therapy designation for bempegaldesleukin (NKTR-214) in combination with Opdivo (nivolumab) for the treatment of patients with untreated advanced melanoma
1 August 2019 - Nektar Therapeutics and Bristol-Myers Squibb today announced that the U.S. FDA has granted breakthrough therapy designation for ...
Posted by Michael Wonder on 01 Aug 2019
Ultragenyx announces submission of new drug application to FDA for UX007 (triheptanoin) for treatment of long-chain fatty acid oxidation disorders
1 August 2019 - Ultragenyx today announced that it has submitted to the U.S. FDA a new drug application for UX007 ...
Posted by Michael Wonder on 01 Aug 2019
Leo Pharma announces U.S. FDA expanded regulatory approvals for Enstilar foam and Taclonex topical suspension in treatment of plaque psoriasis
31 July 2019 - FDA approves Enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in ...
Posted by Michael Wonder on 01 Aug 2019
Trump administration weighs allowing drug imports for cheaper prescriptions
31 July 2019 - The proposal was announced between two Democratic debates, seemingly timed to show that President Trump was also ...
Posted by Michael Wonder on 31 Jul 2019
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies)
31 July 2019 - EMA and the US FDA have published today a report on their joint workshop with stakeholders ...
Posted by Michael Wonder on 31 Jul 2019
FDA approves new monotherapy indication for Merck’s Keytruda (pembrolizumab)
31 July 2019 - Keytruda now approved for recurrent locally advanced or metastatic squamous cell carcinoma of the oesophagus in patients ...
Posted by Michael Wonder on 31 Jul 2019
Momenta Pharmaceuticals announces fast track designation for M281 (nipocalimab) in haemolytic disease of the foetus and newborn
30 July 2019 - Momenta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for M281, Momenta’s ...
Posted by Michael Wonder on 31 Jul 2019
Sunovion announces acceptance by the U.S. FDA of the new drug application for dasotraline for the treatment of adults with moderate-to-severe binge eating disorder
30 July 2019 - Binge eating disorder is estimated to affect 4.1 million Americans and may occur at a rate that ...
Posted by Michael Wonder on 31 Jul 2019
U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer
31 July 2019 - Darolutamide was approved in the U.S. under the FDA priority review designation; approval granted three months ahead ...
Posted by Michael Wonder on 30 Jul 2019
NeuroVive’s NeuroSTAT project receives FDA fast track designation
27 July 2019 - NeuroVive Pharmaceutical today announced that the company’s candidate drug NeuroSTAT, in development for treatment of moderate ...
Posted by Michael Wonder on 30 Jul 2019
FDA requires box warnings for Pfizer drug Xeljanz
26 July 2019 - Patients taking 10 mg dose twice a day could experience a higher risk of blood clots or ...
Posted by Michael Wonder on 30 Jul 2019
Moving from substantial equivalence to substantial improvement for 510(k) ddevevices
29 July 2019 - Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems. ...
Posted by Michael Wonder on 29 Jul 2019
FDA updates draft guidance on rare paediatric disease priority review voucher program
29 July 2019 - The U.S. FDA today issued a revised draft guidance, Rare Paediatric Disease Priority Review Vouchers – ...
Posted by Michael Wonder on 29 Jul 2019
FDA’s Sharpless outlines FDA's 4 top priorities: tech, hiring, modernisation and increased safety
24 July 2019 - Acting U.S. FDA Commissioner Ned Sharpless emailed agency staff yesterday outlining the FDA’s four main priorities. ...
Posted by Michael Wonder on 29 Jul 2019
Harms from uninformative clinical trials
25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...