Blog
RSS FeedPosted by Michael Wonder on 29 Jun 2017
FDA is reviewing generic applications faster, but what about those carryover fees?
28 June 2017 - Now that the FDA plans to fast-track generic drug applications in hopes of spurring competition and ...
Posted by Michael Wonder on 29 Jun 2017
FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
29 June 2017 - The U.S. FDA today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first ...
Posted by Michael Wonder on 26 Jun 2017
The FDA has never approved a drug like this in its 111 year history
25 June 2017 - This cancer drug produced data so incredible that the FDA approved it immediately for a specific genetic ...
Posted by Michael Wonder on 24 Jun 2017
U.S. FDA approves Bevyxxa (betrixaban) first and only anticoagulant for hospital and extended duration prevention of venous thromboembolism in acutely ill medical patients
23 June 2017 - Portola Pharmaceuticals today announced the U.S. FDA has approved Bevyxxa (betrixaban), the first and only anticoagulant ...
Posted by Michael Wonder on 23 Jun 2017
Pfizer provides update on proposed epoetin alfa biosimilar
22 June 2017 - Pfizer today announced that it has received a complete response letter from the U.S. FDA regarding the ...
Posted by Michael Wonder on 23 Jun 2017
Haegarda (C1 esterase inhibitor subcutaneous [human]) FDA approval
23 June 2017 - CSL Limited today announced that the U.S. FDA has approved CSL Behring’s Haegarda (C1 esterase inhibitor ...
Posted by Michael Wonder on 23 Jun 2017
FDA approves first subcutaneous C1 esterase Inhibitor to treat rare genetic disease
22 June 2017 - The U.S. FDA today approved Haegarda, the first C1 esterase inhibitor (human) for subcutaneous administration to ...
Posted by Michael Wonder on 22 Jun 2017
Novartis combination targeted therapy Tafinlar and Mekinist receives FDA approval for BRAF V600E mutant metastatic non-small-cell lung cancer
22 June 2017 - Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 22 Jun 2017
FDA approves Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection in certain blood cancers
22 June 2017 - Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous ...
Posted by Michael Wonder on 21 Jun 2017
U.S. FDA approves Mydayis (mixed salts of a single-entity amphetamine product) – a new once daily option for ADHD symptom control in patients 13 years and older
20 June 2017 - Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, ...
Posted by Michael Wonder on 21 Jun 2017
Neos Therapeutics announces FDA approval of Cotempla XR-ODT (methylphenidate) extended release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 years old
19 June 2017 - First approved methylphenidate extended release orally disintegrating tablet for the treatment of ADHD. ...
Posted by Michael Wonder on 20 Jun 2017
Melinta Therapeutics announces U.S. FDA approval of Baxdela (delafloxacin) for acute bacterial skin and skin structure infections (ABSSSI)
19 June 2017 - Baxdela offers a new option for treatment of adult patients with acute bacterial skin and skin ...
Posted by Michael Wonder on 17 Jun 2017
U.S. FDA approves Humalog Junior KwikPen for the treatment of diabetes
13 June 2017 - The U.S. FDA approved Eli Lilly and Company’s Humalog Junior KwikPen for the treatment of diabetes. ...
Posted by Michael Wonder on 17 Jun 2017
Ipsen announces FDA approval of Dysport (abobotulinumtoxin A) for the treatment of lower limb spasticity in adults
16 June 2017 - Ipsen today announced that the U.S. FDA has expanded the approved use of Dysport (abobotulinumtoxin A) ...
Posted by Michael Wonder on 17 Jun 2017
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
16 June 2017 - Darzelax (daratumumab) approved by U.S. FDA in combination with pomalidomide and dexamethasone for patients with multiple myeloma ...