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RSS FeedPosted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces multiple regulatory milestones for Opdivo (nivolumab) in the U.S. and the European Union
Bristol-Myers Squibb Company today announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the U.S. and European Union. ...
Posted by Michael Wonder on 05 Aug 2015
Adapt Pharma submits NDA to FDA for Narcan (naloxone) nasal spray
Adapt Pharma Limited has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Narcan (naloxone) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Baxter's HyQvia for treatment of adults with primary immunodeficiency
Baxter International Inc. and Halozyme Therapeutics, Inc., today announced that the United States Food and Drug Administration (FDA) approved Baxter's subcutaneous treatment ...
Posted by Michael Wonder on 05 Aug 2015
Actavis and Gedeon Richter announce FDA receipt of NDA resubmission for cariprazine
Actavis plc. and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Actavis' New Drug Application (NDA) resubmission ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves Invega Trinza, first and only four-times-a-year treatment for schizophrenia
There’s a new treatment option for schizophrenia – Invega Trinza (three-month paliperidone palmitate), the first and only schizophrenia medication to be ...
Posted by Michael Wonder on 05 Aug 2015
Novartis tries to get U.S. ban lifted on sale of Neupogen copycat
Novartis AG unit Sandoz asked a U.S. appeals court on Wednesday to lift a preliminary injunction barring it from selling ...
Posted by Michael Wonder on 05 Aug 2015
Novartis gains FDA approval for Promacta providing new option for children, ages 6 and older, with chronic ITP, a rare blood disorder
Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta (eltrombopag olamine) for the treatment of children six ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves weight-management drug Contrave
The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for ...
Posted by Michael Wonder on 05 Aug 2015
The Medicines Company announces FDA approval of Ionsys (fentanyl iontophoretic transdermal system) for the management of acute post-pperative pain for adult patients in the hospital
The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has approved Ionsys (fentanyl iontophoretic transdermal system), the first needle-free, patient-controlled, pre-programmed ...
Posted by Michael Wonder on 05 Aug 2015
Actavis receives FDA approval of Saphris for paediatric patients (age 10-17) for acute treatment of manic or mixed episodes of bipolar I disorder
Actavis plc. today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for Saphris (asenapine) as ...
Posted by Michael Wonder on 05 Aug 2015
Iressa approved by US FDA for first-line treatment of patients with advanced EGFR mutation-positive non small-cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Iressa (gefitinib) tablets, 250mg once daily, for the ...
Posted 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 ...