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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Juno T cell therapy for leukaemia granted FDA breakthrough therapy designation
Juno Therapeutics today announced that the FDA has granted Breakthrough Therapy Designation to the company’s JCAR015 chimeric antigen receptor product ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine for children 4 through 6 years of age
Sanofi Pasteur, the vaccines division of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has approved use ...
Posted by Michael Wonder on 05 Aug 2015
How much should cancer drugs cost?
One of the nation’s top cancer hospitals is challenging the pharmaceutical industry to adopt a more rational approach to drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves radiation medical countermeasure
On March 30, 2015, the FDA approved the use of Neupogen (filgrastim) to treat adult and pediatric patients acutely exposed to ...
Posted by Michael Wonder on 05 Aug 2015
Veloxis announces U.S. FDA approval of Envarsus XR for treatment of kidney transplant patients
Veloxis Pharmaceuticals A/S today announced U.S. Food and Drug Administration (FDA) approval of Envarsus XR (tacrolimus extended-release tablets) for the prophylaxis of ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Teva’s Granix (tbo-filgrastim) injection for self-administration
Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Blincyto to treat a rare form of acute lymphoblastic leukaemia
The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer, Merck and Bristol-Myers Squibb report solid results
Three major U.S. drug companies reported solid first-quarter results despite a strong dollar, amid signs that their investment in pricey ...
Posted by Michael Wonder on 05 Aug 2015
FDA expands approved use of Imbruvica for chronic lymphocytic leukemia
The U.S. FDA today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry ...
Posted by Michael Wonder on 05 Aug 2015
US FDA grants priority review for potential new indication for Brilinta
AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) and ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Afrezza to treat diabetes
The U.S. Food and Drug Administration today approved Afrezza (insulin human) inhalation powder, a rapid-acting inhaled insulin to improve glycemic ...
Posted by Michael Wonder on 05 Aug 2015
Can we get cheaper cancer drugs? More than 100 experts weigh in
Cancer drugs cost way too much and it's time to take steps to bring the price down, 118 of the ...
Posted by Michael Wonder on 05 Aug 2015
FDA provides final guidance on breakthrough product designation
2 Jun 2014 - Last week the FDA finalised a guidance document regarding the use of its four expedited drug approval programmes, ...
Posted by Michael Wonder on 05 Aug 2015
US FDA approves Avastin as ovarian cancer treatment
The Swiss drug maker Roche said on Friday that the Food and Drug Administration had approved its drug Avastin as a treatment for ovarian cancer. Roche said ...
Posted by Michael Wonder on 05 Aug 2015
Dymista approved in children 6 to 11 years of age with seasonal allergic rhinitis
Meda announces the approval by FDA (U.S. Food and Drug Administration) of Dymista, a single formulation azelastine hydrochloride and fluticasone ...