Blog
RSS FeedPosted by Michael Wonder on 13 Aug 2018
Gottlieb: FDA will streamline drug safety evaluations
10 August 2018 - The FDA will soon standardise the way it handles data on the safety and effectiveness of ...
Posted by Michael Wonder on 13 Aug 2018
Regeneron provides regulatory update on Eylea (aflibercept) injection sBLA in wet age-related macular degeneration
13 August 2018 - Regeneron Pharmaceuticals today announced that due to ongoing labelling discussions the U.S. FDA has issued a ...
Posted by Michael Wonder on 13 Aug 2018
Promoting patient interests in implementing the Federal Right to Try Act
13 August 2018 - On May 30, 2018, President Trump signed into law the federal Right to Try Act of 2017,1 ...
Posted by Michael Wonder on 13 Aug 2018
Real world evidence and real world data for evaluating drug safety and effectiveness
13 August 2018 - For hundreds of years, the development of new medical treatments relied on “real-world” experience. ...
Posted by Michael Wonder on 12 Aug 2018
FDA approves new vaginal ring for one year of birth control
10 August 2018 - The U.S. FDA today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined ...
Posted by Michael Wonder on 12 Aug 2018
Alnylam prices first gene silencing drug at $450,000 per patient, but offers money-back guarantee
10 August 2018 - This morning, after 16 years and $2.5 billion in investment, the Cambridge, Massachusetts-based company Alnylam finally ...
Posted by Michael Wonder on 11 Aug 2018
IBM bet billions that Watson could improve cancer treatment. It hasn’t worked.
11 August 2018 - Big Blue’s Watson artificial intelligence product sometimes didn’t say more than doctors already knew. ...
Posted by Michael Wonder on 11 Aug 2018
Castle Creek Pharmaceuticals receives FDA fast track designation for diacerein 1% ointment for treatment of epidermolysis bullosa simplex
9 August 2018 - Biopharmaceutical company currently evaluating diacerein 1% ointment in ongoing DELIVERS study. ...
Posted by Michael Wonder on 11 Aug 2018
FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
10 August 2018 - The U.S. FDA today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused ...
Posted by Michael Wonder on 10 Aug 2018
FDA approves new treatment for a rare genetic disorder, Fabry disease
10 August 2018 - The U.S. FDA today approved Galafold (migalastat), the first oral medication for the treatment of adults with ...
Posted by Michael Wonder on 10 Aug 2018
Ironshore Pharmaceuticals announces FDA approval of Jornay PM (methylphenidate) extended-release capsules CII for the treatment of ADHD
9 August 2018 - The commercial launch of Jornay PM is planned for the first half of 2019. ...
Posted by Michael Wonder on 10 Aug 2018
US FDA approves Arakoda (tafenoquine) tablets for oral use; first preventative antimalarial approved in almost two decades
9 August 2018 - 60 Degrees Pharmaceuticals announced today the U.S. FDA approval of Arakoda (tafenoquine) tablets for the prevention of ...
Posted by Michael Wonder on 09 Aug 2018
Americans fund most of the world’s drug research. Here’s how Trump can end that.
9 August 2018 - President Donald Trump recently released an ambitious, 44-page plan to drive down prescription drug prices. The ...
Posted by Michael Wonder on 09 Aug 2018
Sesen Bio announces Vicinium granted fast track designation by FDA for treatment of non-muscle invasive bladder cancer
9 August 2018 - Sesen Bio today announced that the U.S. FDA has granted fast track designation to Vicinium for the ...
Posted by Michael Wonder on 09 Aug 2018
Glenmark Pharmaceuticals announces FDA acceptance of the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
7 August 2018 - The PDUFA target action date for completion of the FDA review is 21 March 2019. ...