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RSS FeedPosted by Michael Wonder on 14 Sep 2017
FDA approves new treatment for adults with relapsed follicular lymphoma
14 September 2017 - The U.S. FDA today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves first biosimilar for the treatment of cancer
14 September 2017 - Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and ...
Posted by Michael Wonder on 13 Sep 2017
FDA’s Gottlieb plans to close an orphan drug loophole
12 September 2017 - Amid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, ...
Posted by Michael Wonder on 13 Sep 2017
KemPharm announces FDRR process completion and resubmission of the Apadaz NDA
12 September 2017 - FDA has assigned a PDUFA action date of 23 February 2018. ...
Posted by Michael Wonder on 13 Sep 2017
Array BioPharma announces FDA acceptance for review of binimetinib and encorafenib new drug applications for patients with advanced BRAF-mutant melanoma
12 September 2017 - Array BioPharma today announced that the U.S. FDA has accepted for review its new drug applications to ...
Posted by Michael Wonder on 12 Sep 2017
Shire receives FDA fast track designation for SHP607 for the prevention of chronic lung disease in extremely premature infants
12 September 2017 - Shire today announced that the United States FDA has granted fast track designation for SHP607 for ...
Posted by Michael Wonder on 12 Sep 2017
FDA is advancing the goals of the Orphan Drug Act
12 September 2017 - Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests ...
Posted 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
FDA accepts Adello’s biosimilar biologics license application for a proposed filgrastim biosimilar
11 September 2017 - U.S.-based Adello Biologics today announced that U.S. FDA has accepted for review the company’s biologics license ...
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 ...