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May 21, 2014
Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer.
May 14, 2014
FDA clarifies stability data recommendations for abbreviated new drug applications.
February 02, 2014
High technology assessments are having an impact on biosimilars development in Europe.
December 18, 2013
FDA and EMA launch initiative to share bioequivalence inspection information.
December 12, 2013
OGD is under pressure to improve review operations.
December 02, 2013
A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.
September 30, 2013
FDA publishes guidance on ANDA submissions.
July 30, 2013
Depomed, Inc. announced that FDA has accepted for filing a new drug application (NDA) from Mallinckrodt for MNK-795.
June 28, 2013
The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.
May 08, 2013
EMA streamlines orphan drug application procedure.