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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Vernalis and Tris Pharma receive FDA approval of NDA for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex)
Vernalis plc and Tris Pharma Inc. today announce that the U.S. Food and Drug Administration (FDA) has approved the New ...
Posted by Michael Wonder on 05 Aug 2015
Ipsen announces FDA acceptance of filing for Dysport in the treatment of upper limb spasticity in adult patients
Ipsen today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA issues complete response letter to sNDA seeking to expand the label for Invega Sustenna
Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding the ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV
The U.S. Food and Drug Administration today approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Avastin for ovarian cancer
Roche has garnered a new indication for Avastin from US regulators, this time in combination with chemotherapy for the treatment ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb and AbbVie Receive U.S. FDA breakthrough therapy designation for elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma
Bristol-Myers Squibb Company and AbbVie today announced that the U.S. Food and Drug Administration (FDA) has granted elotuzumab, an investigational humanized monoclonal ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Ofev to treat idiopathic pulmonary fibrosis
The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF). ...
Posted by Michael Wonder on 05 Aug 2015
Novartis gains FDA approval for Signifor LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
Novartis announced today that the US Food and Drug Administration (FDA) has approved Signifor long-acting release (LAR) (pasireotide) for injectable suspension, for ...
Posted by Michael Wonder on 05 Aug 2015
Pozen’s Yosprala receives complete response letter from the FDA
Pozen Inc, a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their investigational drug candidates Yosprala 81/40 and 325/40 ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first biosimilar product Zarxio
The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States. ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves first generic versions of celecoxib
The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid ...
Posted by Michael Wonder on 05 Aug 2015
US FDA accepts for review a biologics license application for Merck and Sanofi Pasteur’s investigational paediatric hexavalent vaccine
Merck, known as MSD outside the United States and Canada, and Sanofi Pasteur, the vaccines division of Sanofi, announced today ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves additional antibacterial treatment for plague
The U.S. Food and Drug Administration today approved Avelox (moxifloxacin) to treat patients with plague, a rare and potentially fatal ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Lymphoseek to help determine the extent of head and neck cancer in the body
The U.S. Food and Drug Administration today approved a new use for Lymphoseek (technetium 99m tilmanocept) Injection, a radioactive diagnostic ...
Posted by Michael Wonder on 05 Aug 2015
Janssen files four-times-a-year schizophrenia shot
Johnson & Johnson group Janssen has filed an application in the US to market a three-month injectable formulation of paliperidone palmitate for ...