Blog
RSS FeedPosted by Michael Wonder on 04 Aug 2016
Drugmakers split on whether to include interchangeability statement in biosimilar labels
3 August 2016 - Drug, biologic and biosimilar companies’ comments on US FDA draft guidance on biosimilar labeling reveals a major ...
Posted by Michael Wonder on 04 Aug 2016
Microbion Corporation announces FDA has granted fast track designation to MBN-101 for the adjunctive treatment of moderate and severe diabetic foot ulcer infections
3 August 2016 - Microbion today announced that the U.S. FDA has granted MBN-101 fast track designation for adjunctive treatment of ...
Posted by Michael Wonder on 04 Aug 2016
More on FDA breakthrough therapies
4 August 2016 - The FDA has granted 148 breakthrough therapy designations as at 3 August 2016. Most of the ...
Posted by Michael Wonder on 02 Aug 2016
Ipsen announces FDA approval of Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in children aged two and older
1 August 2016 - First and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity. ...
Posted by Michael Wonder on 02 Aug 2016
Vaccinex receives FDA fast track designation for VX15 antibody for the treatment of Huntington’s disease
1 August 2016 - Vaccinex today announced that the U.S. FDA has granted fast track designation for VX15 as a potential ...
Posted by Michael Wonder on 01 Aug 2016
MEI Pharma's pracinostat receives breakthrough therapy designation from FDA for treatment in combination with azacitidine of patients with newly diagnosed acute myeloid leukaemia unfit for intensive chemotherapy
1 August 2016 - MEI Pharma announced today that the U.S. FDA has granted breakthrough therapy designation for the investigational drug ...
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 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 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
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
Valeant Pharmaceuticals receives complete response letter from the FDA
22 July 2016 - FDA letter related to current good manufacturing practice at Bausch & Lomb facility. ...