Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2019
FDA issues draft guidance regarding clinical trial design for newborns
31 July 2019 - Today, the U.S. Food and Drug Administration issued the draft guidance, General Clinical Pharmacology Considerations for Neonatal ...
Posted by Michael Wonder on 04 Aug 2019
Vas Narasimhan of Novartis: ‘we are not at all prepared for a pandemic’
1 August 2019 - The son of Indian immigrants read Greek philosophy and worked at McKinsey before joining a giant drug ...
Posted by Michael Wonder on 03 Aug 2019
FDA approves first therapy for rare joint tumour
2 August 2019 - Today, the U.S. FDA granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients ...
Posted by Michael Wonder on 02 Aug 2019
FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications
31 July 2019 - The FDA and the EMA are publishing the discussion and main conclusions from a workshop held ...
Posted by Michael Wonder on 02 Aug 2019
Toppling the ethical balance — health care refusal and the Trump administration
31 July 2019 - For nearly 50 years, U.S. federal law has permitted medical professionals and religious institutions to refuse, ...
Posted by Michael Wonder on 01 Aug 2019
Eton Pharmaceuticals announces FDA acceptance of new drug application for ET-105
1 August 2019 - ET-105 assigned Prescription Drug User Fee Act target action date of 17 March 2020. ...
Posted 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 ...