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RSS FeedPosted 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 ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA accepts Eisai's NDA for Banzel (rufinamide) as adjunctive treatment in paediatric patients with Lennox-Gastaut syndrome
Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New ...
Posted by Michael Wonder on 05 Aug 2015
Teva announces FDA approval of ProAir RespiClick
Teva Pharmaceutical Industries Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick (albuterol sulfate) inhalation powder, a breath-actuated, ...
Posted by Michael Wonder on 05 Aug 2015
U.S. FDA approves dual-chamber syringe for Abilify Maintena (aripiprazole) extended-release injectable suspension for the treatment of schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has ...
Posted by Michael Wonder on 05 Aug 2015
New indication for Vimpat (lacosamide): UCB’s anti-epileptic drug approved by FDA as monotherapy in the treatment of patients with partial-onset seizures
1 September 2014 – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug ...
Posted by Michael Wonder on 05 Aug 2015
FDA seeks $4.9 billion for FY 2016 to implement the FDA Food Safety Modernization Act and improve the quality and safety of the medical products Americans use
The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health ...
Posted by Michael Wonder on 05 Aug 2015
Amgen receives FDA breakthrough therapy designation for investigational BiTE antibody blinatumomab in acute lymphoblastic leukaemia
Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational bispecific T cell engager (BiTE) ...