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RSS FeedPosted by Michael Wonder on 16 Nov 2017
FDA expands approval of Sutent to reduce the risk of kidney cancer returning
16 November 2017 - FDA approves adjuvant treatment for adult patients at a high risk of kidney cancer returning after nephrectomy. ...
Posted by Michael Wonder on 16 Nov 2017
FDA approves Genentech’s Gazyva for previously untreated advanced follicular lymphoma
16 November 2017 - The first treatment option to demonstrate superior progression-free survival over standard-of-care Rituxan-based therapy. ...
Posted by Michael Wonder on 16 Nov 2017
FDA approves new treatment to prevent bleeding in certain patients with haemophilia A
16 November 2017 - The U.S. FDA today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in ...
Posted by Michael Wonder on 16 Nov 2017
Statement from FDA Commissioner on FDA’s comprehensive new policy approach to facilitating the development of innovative regenerative medicine products to improve human health
16 November 2017 - One of the most promising fields of science is the area of cell-based therapies and their ...
Posted by Michael Wonder on 16 Nov 2017
FDA announces comprehensive regenerative medicine policy framework
16 November 2017 - Framework aims to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy. ...
Posted by Michael Wonder on 16 Nov 2017
Noden Pharma announces FDA approval of Tekturna (aliskiren) oral pellets for the treatment of hypertension in adults and children 6 years of age and older
15 November 2017 - Noden Pharma announced today the approval by the U.S. FDA of Tekturna (aliskiren) oral pellets for the ...
Posted by Michael Wonder on 16 Nov 2017
Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS
15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...
Posted by Michael Wonder on 15 Nov 2017
Trump's HHS secretary nominee boosted drug prices while at Eli Lilly
14 November 2017 - His record suggests he’s unlikely to push pricing policies that would hit pharmaceutical companies’ pocketbooks. ...
Posted by Michael Wonder on 15 Nov 2017
FDA approves treatment for rare genetic enzyme disorder
15 November 2017 - The U.S. FDA today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an ...
Posted by Michael Wonder on 15 Nov 2017
First digital pill approved to worries about biomedical ‘Big Brother’
13 November 2017 - For the first time, the FDA has approved a digital pill — a medication embedded with ...
Posted by Michael Wonder on 15 Nov 2017
FDA grants marketing authorisation of the first device for use in helping to reduce the symptoms of opioid withdrawal
15 November 2017 - Today, the U.S. FDA granted a new indication to an electric stimulation device for use in ...
Posted by Michael Wonder on 15 Nov 2017
FDA unveils a streamlined path for the authorisation of tumour profiling tests alongside its latest product action
15 November 2017 - The U.S. FDA today authorised Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer ...
Posted by Michael Wonder on 15 Nov 2017
Janet Woodcock wants you to know the FDA is not picking speed over safety in drug approvals
14 November 2017 - What is the biggest difference in working at the FDA under its new commissioner, Scott Gottlieb? ...
Posted by Michael Wonder on 15 Nov 2017
Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib
15 November 2017 - Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival. ...
Posted by Michael Wonder on 15 Nov 2017
Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma
14 November 2017 - FDA approval based on Phase III programme demonstrating up to 51% reduction in asthma exacerbations, significant improvement ...