Blog
RSS FeedPosted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb receives complete response letter from U.S. Food and Drug Administration for daclatasvir, an investigational treatment for hepatitis C
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding ...
Posted by Michael Wonder on 05 Aug 2015
Gilead submits new drug application to U.S. Food and Drug Administration for fixed-dose combination of emtricitabine/tenofovir alafenamide for HIV treatment
Gilead Sciences, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 05 Aug 2015
Bristol-Myers Squibb announces plans for third quarter submission of a biologics license application for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, for previously treated advanced melanoma
Bristol-Myers Squibb Company today announced that, following discussions with the U.S. Food and Drug Administration (FDA), the company is planning a ...
Posted by Michael Wonder on 05 Aug 2015
Alexion completes rolling BLA submission to U.S. FDA for asfotase alfa as a treatment for patients with pypophosphatasia
Alexion Pharmaceuticals, Inc. announced today completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA has granted priority review for Olysio in combination with sofosbuvir supplementary New Drug Application
Medivir AB announces that the Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Lenvima for a type of thyroid cancer
The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer ...
Posted by Michael Wonder on 05 Aug 2015
Vertex submits supplemental new drug application (sNDA) to U.S. Food and Drug Administration for use of Kalydeco (ivacaftor) in people 18 and older with cystic fibrosis who have the R117H mutation
Vertex Pharmaceuticals Incorporated today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ...
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
Allergan announces FDA approves revised indication for Ozurdex (dexamethasone intravitreal implant) 0.7 mg for the treatment of diabetic macular oedema
Allergan, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves anti-clotting drug Savaysa
The U.S. Food and Drug Administration today approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke ...
Posted by Michael Wonder on 05 Aug 2015
Investigation medicine venetoclax receives breakthrough therapy designation in relapsed or refractory chronic lymphocytic leukaemia in previously treated patients with the 17P deletion genetic mutation
AbbVie today announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in ...
Posted by Michael Wonder on 05 Aug 2015
FDA grants breakthrough therapy designation to Eisai's lenvatinib for the potential treatment of metastatic renal cell carcinoma
Eisai Inc. announced today the U.S. Food and Drug Administration (FDA) granted lenvatinib, the company's multiple receptor tyrosine kinase inhibitor, ...
Posted by Michael Wonder on 05 Aug 2015
Sanofi receives FDA approval of one-daily basal insulin Toujeo
Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain ...
Posted by Michael Wonder on 05 Aug 2015
FDA approves Velcade (bortezomib) for injection for previously untreated patients with mantle cell lymphoma
Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, today announced that the U.S. Food and ...