Blog
RSS FeedPosted by Michael Wonder on 01 Aug 2016
Shire announces FDA approval of Adynovate with Baxject III reconstitution system
1 August 2016 - New system reduces number of steps in the treatment process for haemophilia A patients on Adynovate [antihemophilic ...
Posted by Michael Wonder on 01 Aug 2016
FDA approves Qbrelis, the first and only lisinopril 1 mg/mL oral solution for pediatric patients 6 years of age and older
29 July 2016 - Silvergate Pharmaceuticals today announced that the U.S. FDA approved Qbrelis (lisinopril) oral solution, the first and only ...
Posted by Michael Wonder on 31 Jul 2016
Caladrius Biosciences receives FDA fast track designation for CLBS03 to treat recent onset type 1 diabetes
28 July 2016 - First reported fast track designation for a type 1 diabetes treatment. ...
Posted by Michael Wonder on 31 Jul 2016
ADMA Biologics receives complete response letter from FDA for pending biologics license application
29 Jul 2016 - ADMA Biologics announced that the U.S. FDA has issued a complete response letter to the company’s biologics ...
Posted by Michael Wonder on 30 Jul 2016
FDA approvals for the first 6 months of 2016
29 July 2016 - The FDA approved 13 new drugs in the first 6 months of this year. ...
Posted by Michael Wonder on 30 Jul 2016
Shire’s SHP626 (volixibat) receives FDA fast track designation for an investigational treatment for adults who have non-alcoholic steatohepatitis with liver fibrosis
29 July 2016 - Shire today announced that the United States FDA has granted fast track designation for SHP626 (volixibat) for ...
Posted by Michael Wonder on 28 Jul 2016
FDA approves Adlyxin to treat type 2 diabetes
28 July 2016 - The U.S. FDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along ...
Posted by Michael Wonder on 27 Jul 2016
FDA continues steady reduction of generic drug application backlog
25 July 2016 - As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US FDA ...
Posted by Michael Wonder on 26 Jul 2016
Merck receives breakthrough therapy designation from FDA and PRIME status from EMA for investigational Ebola Zaire vaccine (V920)
25 July 2016 - Merck today announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live ...
Posted by Michael Wonder on 26 Jul 2016
Daratumumab receives breakthrough therapy designation from U.S. Food and Drug Administration in combination with standard of care regimens for previously treated multiple myeloma
26 July 2016 - Marks second breakthrough therapy designation for daratumumab. ...
Posted by Michael Wonder on 25 Jul 2016
AbbVie receives U.S. FDA approval of once daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C
25 July 2016 - New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of Viekira ...
Posted by Michael Wonder on 25 Jul 2016
Ocular Therapeutix receives complete response letter from FDA for its NDA for Dextenza for the treatment of post-surgical ocular pain
25 July 2016 - Outstanding items pertain to manufacturing process and controls. ...
Posted by Michael Wonder on 24 Jul 2016
Generic Crestor wins approval, dealing a blow to AstraZeneca
20 July 2016 - The FDA said Wednesday that it had approved generic versions of the blockbuster cholesterol-lowering pill Crestor, rejecting ...
Posted by Michael Wonder on 22 Jul 2016
Spark Therapeutics and Pfizer announce receipt of FDA breakthrough therapy designation for SPK-9001 for the treatment of hemophilia B
21 July 2016 - Spark Therapeutics and Pfizer announced today that the U.S. FDA has granted breakthrough therapy designation to SPK-9001, ...
Posted by Michael Wonder on 22 Jul 2016
Valeant Pharmaceuticals receives complete response letter from the FDA
22 July 2016 - FDA letter related to current good manufacturing practice at Bausch & Lomb facility. ...