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RSS FeedPosted by Michael Wonder on 12 Sep 2017
Streamlined FDA reviews fail to catch dangerous glitches in health software, study finds
12 September 2017 - The FDA carefully polices many categories of drugs and devices. ...
Posted by Michael Wonder on 12 Sep 2017
Why is the FDA chief so worried about pharma profits?
11 September 2017 - Developing new drugs is a costly business. So, too, is paying for the ever more expensive ...
Posted by Michael Wonder on 12 Sep 2017
Sandoz proposed biosimilar rituximab accepted for review by the FDA
12 September 2017 - Sandoz believes the comprehensive data package submitted to the FDA for review confirms that our biosimilar rituximab ...
Posted by Michael Wonder on 10 Sep 2017
Sobi receives approval from the FDA for once-daily dosing frequency of Orfadin for the treatment of HT-1
5 September 2017 - Sobi has received approval from the U.S. FDA for a reduced dosing frequency for Orfadin (nitisinone) ...
Posted by Michael Wonder on 09 Sep 2017
Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study
7 September 2017 - Mostaghim et al. set out to determine if drugs approved through the FDA’s expedited development and review ...
Posted by Michael Wonder on 09 Sep 2017
Sanofi and Regeneron announce that cemiplimab (REGN2810) has received FDA breakthrough therapy designation for advanced cutaneous squamous cell carcinoma
8 September 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. FDA has granted breakthrough therapy designation ...
Posted by Michael Wonder on 07 Sep 2017
Statement from FDA Commissioner Scott Gottlieb on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy
7 September 2017 - As the science governing allergies and diets continues to evolve, so do expert recommendations around how best ...
Posted by Michael Wonder on 07 Sep 2017
FDA’s plan to engage the public in the agency’s new effort to strengthen and modernise FDA’s regulatory framework
7 September 2017 - We’re at a moment of extraordinary opportunity to improve the public health. New innovations are giving us ...
Posted by Michael Wonder on 07 Sep 2017
NeuroRx awarded FDA fast track designation for first drug regimen targeting suicide in bipolar depression
6 September 2017 - NeuroRx has been granted fast track status by the US FDA for its sequential therapy of NRX-100 ...
Posted by Michael Wonder on 07 Sep 2017
Novimmune receives rare paediatric disease designation from the FDA for its lead drug emapalumab
5 September 2017 - Providing eligibility is confirmed at the time of approval of emapalumab for the treatment of primary haemophagocytic ...
Posted by Michael Wonder on 07 Sep 2017
Enzyvant receives FDA rare paediatric disease designation for investigational therapy RVT-802
5 September 2017 - RVT-802 has also received breakthrough therapy designation, regenerative medicine advanced therapy designation, and orphan drug designation from ...
Posted by Michael Wonder on 06 Sep 2017
We may soon learn just how flexible Scott Gottlieb's FDA is
6 September 2017 - One the FDA's biggest controversies is coming back to test its new leadership. ...
Posted by Michael Wonder on 06 Sep 2017
AbbVie submits new drug application to U.S. FDA for investigational oral treatment elagolix for the management of endometriosis with associated pain
6 September 2017 - If approved by the FDA, elagolix will be the first new medical management treatment option for endometriosis-associated ...
Posted by Michael Wonder on 05 Sep 2017
Interoperability: FDA’s final guidance on smart, safe, medical device interactions
5 September 2017 - Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is ...
Posted by Michael Wonder on 04 Sep 2017
At $475,000, new cancer drug raises thorny questions about drug pricing — and value
4 September 2017 - A first-of-its-kind cancer treatment is generating unbridled excitement — but also underscoring intense concerns over pricing ...