Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...
Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the ...
On Friday, the Food and Drug Administration announced a new pilot prioritization program for the review of abbreviated new drug applications that aims to spur and reward investment in U.S. drug ...
Following successful small-animal trials that confirmed bioequivalence, BioNxt is now taking the final preclinical step to prepare its sublingual Cladribine formulation for human testing. The upcoming ...
Astellas will push the agency for more rigorous bioequivalence testing of generic immuosuppressants. Sandoz will launch the first generic version of Astellas’ transplant rejection drug, Prograf ...
WALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central ...
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