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RSS FeedPosted by Michael Wonder on 31 Oct 2017
FDA approves new treatment for adults with mantle cell lymphoma
31 October 2017 - The U.S. FDA today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle ...
Posted by Michael Wonder on 30 Oct 2017
Bayer receives FDA approval for Xarelto 10 mg once daily for the extended treatment of venous thromboembolism
30 October 2017 - Rivaroxaban (Xarelto) 10 mg once daily significantly reduces the risk of recurrent venous thromboembolism compared with aspirin ...
Posted by Michael Wonder on 26 Oct 2017
Tesaro announces U.S. FDA approval of Varubi IV for delayed nausea and vomiting associated with cancer chemotherapy
25 October 2017 - Availability of new formulation offers healthcare providers the flexibility to choose oral or IV administration. ...
Posted by Michael Wonder on 24 Oct 2017
FDA approves Soliris (eculizumab) for the treatment of patients with generalised myasthenia gravis
23 October 2017 - First FDA approved treatment in more than 60 years for patients with generalised myasthenia gravis, a ...
Posted by Michael Wonder on 24 Oct 2017
US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type 2 diabetes
23 October 2017 - New formulation of once-weekly exenatide in an improved device provides significant HbA1c reduction with added benefit ...
Posted by Michael Wonder on 24 Oct 2017
United Therapeutics announces FDA approval of third generation nebuliser for the Tyvaso inhalation system
23 October 2017 - United Therapeutics today announced approval by the U.S. FDA of a new inhalation device, called the ...
Posted by Michael Wonder on 23 Oct 2017
GSK wins U.S. shingles vaccine approval, UK nod for gene therapy
23 October 2017 - GlaxoSmithKline has won U.S. approval for a new and improved shingles vaccine, the second of three ...
Posted by Michael Wonder on 21 Oct 2017
Janssen receives two U.S. FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis
20 October 2017 - Simponi Aria is the only fully-human anti-TNF-alpha infused therapy now approved for psoriatic arthritis, ankylosing spondylitis ...
Posted by Michael Wonder on 21 Oct 2017
Shingrix approved in the US for prevention of shingles in adults aged 50 and over
20 October 2017 - Pooled clinical trial results showed > 90 percent efficacy across all age groups. ...
Posted by Michael Wonder on 20 Oct 2017
Antares Pharma receives complete response letter from the FDA for Xyosted
20 October 2017 - Antares Pharma announced that today it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 19 Oct 2017
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
18 October 2017 - The U.S. FDA today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with ...
Posted by Michael Wonder on 16 Oct 2017
FDA clears new robotically-assisted surgical device for adult patients
13 October 2017 - Today, the U.S. FDA cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can ...
Posted by Michael Wonder on 14 Oct 2017
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate-to-severe plaque psoriasis
13 October 2017 - Findings from a registrational study showed Stelara led to significant skin clearance results at week 12. ...
Posted by Michael Wonder on 13 Oct 2017
A ‘holy cow’ moment: the FDA approved a record number of generics
12 October 2017 - As the FDA attempts to foster more competition in the prescription drug market, the agency appears ...
Posted by Michael Wonder on 12 Oct 2017
AcelRx Pharmaceuticals receives complete response letter from the FDA for Dsuvia NDA
12 October 2017 - AcelRx Pharmaceuticals today announced that it received a complete response letter from the U.S FDA regarding its ...