Blog
RSS FeedPosted 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
Will Trump’s FDA relax standards for drug approval? We’ll get a clue soon with decision on Portola’s anticoagulant
21 June 2017 - Is the FDA under new Commissioner Scott Gottlieb willing to be flexible with the rules, and ...
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 22 Jun 2017
Seattle Genetics submits supplemental biologics license application to FDA for Adcetris (brentuximab vedotin) in cutaneous T cell lymphoma
20 June 2017 - Application based on clinical trial results from the Phase 3 ALCANZA and Phase 2 investigator sponsored ...
Posted by Michael Wonder on 21 Jun 2017
FDA working to lift barriers to generic drug competition
21 June 2017 - Too many patients are being priced out of the medicines they need. ...
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
FDA to clear path for drugs aimed at cancer causing genes
21 June 2017 - FDA Commissioner Gottlieb talks about push before Senate panel. ...
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 20 Jun 2017
Priority generic drug reviews: new FDA draft guidance
19 June 2017 - In preparation of its commitments under the second Generic Drug User Fee Amendments, the US FDA ...
Posted by Michael Wonder on 20 Jun 2017
FDA grants fast track designation to Axovant's nelotanserin for visual hallucinations in dementia with Lewy bodies
19 June 2017 - Axovant Sciences today announced that the U.S. FDA has granted fast track designation to its investigational ...
Posted by Michael Wonder on 19 Jun 2017
Emerging use of early health technology assessment in medical product development: a scoping review of the literature
20 June 2017 - Early health technology assessment is increasingly being used to support health economic evidence development during early stages ...
Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018. ...
Posted by Michael Wonder on 18 Jun 2017
Fibrocell receives rare paediatric disease designation from FDA for FCX-013 for treatment of localised scleroderma
12 June 2017 - Gene therapy candidate under control of RheoSwitch therapeutic system technology is potential first-in-class treatment for chronic ...