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FDA 2014 Approvals Outpace Those of 2013
The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about.
The FDA offered up an early retrospective of the 2014 year of approvals Friday with a rundown the regulator feels pretty good about.
“Our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel drugs in 2014 compared to 27 in 2013,” FDA commissioner Margaret Hamburg wrote on the agency's FDA Voice blog.
The approval pattern for the year—with a few weeks to go—shakes out as follows:
- 15 of this year's approved new molecular entities were for orphan drugs, the highest number since the Orphan Drug Act passed in 1983.
- The FDA approved almost 75% of novel drugs after one review cycle
- 57% of the approved drugs had Priority Review tags, speeding up the approval process
- 37% of novel drugs were on the Fast Track review route
Read more: http://bit.ly/1uJKpQX
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
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Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
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Early Involvement Critical in Treating Immunotherapy-Induced Overlap Syndrome
April 19th 2024A series of case studies reveals the importance of early diagnosis and involvement of special teams of clinicians when dealing with potential cases of overlap syndrome, which encompasses myocarditis, myasthenia gravis, and immune checkpoint inhibitor–related myositis.
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Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
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