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April 06, 2017
A new study in NEJM compares the regulatory review processes of FDA and EMA.
April 05, 2017
What are the pros, cons, and practicalities of moving pharma manufacturing back to the US? \
Deutetrabenazine is the first deuterated product approved by FDA, approval represents the first new treatment option for chorea associated with Huntington’s disease in nearly a decade.
April 03, 2017
GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.
March 22, 2017
Will new generic drugs bring the cost of medicines down in the way policy makers hope?
March 09, 2017
The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.
March 01, 2017
President Trump calls for faster FDA approvals and lower drug prices.
February 24, 2017
The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.
In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.
February 23, 2017
The authors discuss regulatory and patent issues with combination products.