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RSS FeedPosted by Michael Wonder on 05 Aug 2015
FDA approves new formulation of Minocin (minocycline) for injection
The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for a new ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves two higher dosage strengths of Zubsolv
Orexo AB announced today that it has received approval from the U.S. Food and Drug Administration (FDA) of two higher dosage strengths ...
Posted by Michael Wonder on 05 Aug 2015
Supplemental new drug applications for Invega Sustenna (paliperidone palmitate) submitted to the U.S. FDA for the treatment of schizoaffective disorder
Janssen Pharmaceuticals, Inc., today announced the submission of supplemental New Drug Applications (sNDAs) for once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Striverdi Respimat to treat chronic obstructive pulmonary disease
Today, the U.S. Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new dosing option for CSL Behring’s Hizentra
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has expanded the administration options for Hizentra, immune globulin subcutaneous ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves supplemental new drug applications for once-monthly long-acting therapy Invega Sutenna (paliperidone palmitate) for the treatment of schizoaffective disorder
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) ...
Posted by Michael Wonder on 05 Aug 2015
Aprecia Pharmaceuticals receives FDA acceptance for filing for first product using advanced ZipDose technology
Aprecia Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring
The U.S. Food and Drug Administration today allowed marketing of the first set of mobile medical apps that allow people ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves Rockwell's Triferic for iron replacement and maintenance of haemoglobin in haemodialysis patients
Rockwell Medical, Inc, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves new antiplatelet drug used during heart procedure
The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood ...
Posted by Michael Wonder on 05 Aug 2015
Apotex announces FDA has accepted for filing its biosimilar application for pegfilgrastim
Apotex Inc., the largest Canadian owned pharmaceutical company, announced today that the US Food and Drug Administration has accepted for ...
Posted by Michael Wonder on 05 Aug 2015
Allergan receives FDA approval for Ozurdex (dexamethasone intravitreal implant) 0.7 mg as treatment option for diabetic macular oedema in certain patients
Allergan announced that it has received approval from the U.S. Food and Drug Administration (FDA) for Ozurdex (dexamethasone intravitreal implant) 0.7 mg as ...
Posted by Michael Wonder on 05 Aug 2015
High prices for drugs attacked at meeting
In a sign of growing frustration with rising drug prices, a prominent cancer specialist on Sunday sharply criticized the costs ...
Posted by Michael Wonder on 05 Aug 2015
U.S. Food and Drug Administration accepts supplemental biologics license application for Opdivo (nivolumab) in patients with previously untreated advanced melanoma
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental ...
Posted by Michael Wonder on 05 Aug 2015
Biogen Idec's Plegridy (peginterferon beta-1a) approved in the US for the treatment of multiple sclerosis
Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved Plegridy (peginterferon beta-1a), a new treatment for people with ...