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RSS FeedPosted by Michael Wonder on 30 Nov 2017
Merck receives FDA approval for Isentress (raltegravir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in newborns weighing at least 2 kg
29 November 2017 - Only integrase inhibitor approved in the United States for treatment of HIV-1 in newborns from birth ...
Posted by Michael Wonder on 22 Nov 2017
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
22 November 2017 - FDA approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, which can make small adjustments ...
Posted by Michael Wonder on 21 Nov 2017
FDA approval of tisagenlecleucel
21 November 2017 - Promise and complexities of a $475, 000 cancer drug. ...
Posted by Michael Wonder on 21 Nov 2017
FDA approves first two-drug regimen for certain patients with HIV
21 November 2017 - FDA approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with ...
Posted 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
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 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
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 ...
Posted by Michael Wonder on 14 Nov 2017
EMD Serono receives FDA approval for new Gonal-f RFF Redi-ject pen
13 November 2017 - Redesigned pen injector developed based on insights of healthcare professionals and fertility patients. ...