Blog
RSS FeedPosted by Michael Wonder on 17 Jun 2017
FDA science: working at the speed of emerging technologies
16 June 2017 - Let’s face it, we’ve all gotten used to nearly instant access to almost anything. ...
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 ...
Posted by Michael Wonder on 17 Jun 2017
Adamis wins U.S. approval to sell EpiPen rival, shares soar
15 June 2017 - Adamis Pharmaceuticals said on Thursday it received U.S. approval for its emergency epinephrine syringes to treat ...
Posted by Michael Wonder on 15 Jun 2017
FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus
15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...
Posted by Michael Wonder on 15 Jun 2017
Fostering medical innovation: a plan for digital health devices
15 June 2017 - It is incumbent upon FDA to ensure that we have the right policies in place to promote ...
Posted by Michael Wonder on 14 Jun 2017
FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of IgA nephropathy
13 June 2017 - Omeros’ second Phase 3 clinical program for OMS721 slated to begin this year. ...
Posted by Michael Wonder on 14 Jun 2017
How creative FDA regulation led to first-in-the-world approval of a cutting edge heart valve
14 June 2017 - Nearly six years ago FDA approved an artificial transcatheter heart valve to treat patients having severe ...
Posted by Michael Wonder on 14 Jun 2017
Pfizer and Lilly receive FDA fast track designation for tanezumab
13 June 2017 - Global Phase 3 program is studying potential new treatment option for millions of people living with chronic ...
Posted by Michael Wonder on 13 Jun 2017
Statement from FDA Commissioner Scott Gottlieb, M.D. – FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties
13 June 2017 - Last month, I asked my colleagues at the FDA to identify what additional and more forceful steps ...
Posted by Michael Wonder on 12 Jun 2017
Drug prices: this time is different
11 June 2017 - Yet another congressional hearing on drug prices is on tap. Investors should resist the temptation to ...
Posted by Michael Wonder on 12 Jun 2017
Supreme Court speeds copycat biologic drugs to market
12 June 2017 - The U.S. Supreme Court on Monday cut the time it will take for copycat versions of ...
Posted by Michael Wonder on 12 Jun 2017
Coherus Biosciences receives complete response letter from FDA for its biologics license application for CHS-1701 (pegfilgrastim biosimilar candidate)
12 June 2017 - Coherus BioSciences today announced that the U.S. FDA has issued a complete response letter for its ...
Posted by Michael Wonder on 12 Jun 2017
Regulators in EU, Japan and US take steps to facilitate development of new antibiotics
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...
Posted by Michael Wonder on 11 Jun 2017
The FDA either will find its voice, or get its comeuppance, under Commissioner Gottlieb
10 June 2017 - Dr. Scott Gottlieb, the new Commissioner of the FDA, has a big job and a lot ...