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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Jardiance to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first-line use of Vectibix (panitumumab) plus FOLFOX for patients with wild-type KRAS metastatic colorectal cancer
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Vectibix (panitumumab) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new drug to treat heart failure
The U.S. Food and Drug Administration today approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration accepts filing of new drug application for empagliflozin/metformin fixed-dose combination
The U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for empagliflozin plus immediate-release ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first prescription drug made through 3D printing
The Food and Drug Administration has approved the first prescription drug made through 3D printing: a dissolvable tablet that treats seizures. ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives U.S. FDA breakthrough therapy designation for investigational HIV-1 attachment inhibitor for heavily treatment-experienced patients
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational ...
Posted by Michael Wonder on 05 Aug 2015
Eagle Pharmaceuticals’ RTU bivalirudin NDA accepted for filing
Eagle Pharmaceuticals, Inc. today announced that the 505(b)(2) New Drug Application (NDA) for its novel ready-to-use bivalirudin product (“RTU bivalirudin”) has ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Trulicity to treat type 2 diabetes
18 Septemner 2014 - The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve ...
Posted by Michael Wonder on 05 Aug 2015
‘Viagra for women’ is backed by an F.D.A. panel
After an intense lobbying campaign, a federal advisory panel recommended approval of what would become the first drug to treat ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Bayer’s Gadavist (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age
Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist (gadobutrol) injection for use with magnetic ...
Posted by Michael Wonder on 05 Aug 2015
Pfizer announces FDA acceptance for review of a new drug application for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride)
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) ...
Posted by Michael Wonder on 05 Aug 2015
Merck receives FDA breakthrough therapy designation for Keytruda (pembrolizumab) in advanced non small-cell lung cancer
Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) ...