The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...
NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry ...
Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...
U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA) said on Friday that the U.S. Food and Drug Administration (FDA) ...
The NDA is supported by data from part A of the phase 2 PROSPECT trial, which evaluated tirabrutinib in 48 adult patients with R/R PCNSL.
FDA accepted a new drug application for tirabrutinib in relapsed or refractory PCNSL.
Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), today announced that the U.S. Food and Drug Administration ...
Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to ...
The FDA has accepted the new drug application (NDA) for tirabrutinib (ONO-4059), a highly selective, irreversible, second-generation Bruton tyrosine kinase (BTK) inhibitor developed for the treatment ...
Please provide your email address to receive an email when new articles are posted on . ER-100 is the first cellular rejuvenation therapy to receive clearance for human clinical trials. A phase 1 ...
Approval will broaden the NARCAN® Nasal Spray portfolio, and improve cost-effectiveness byincreasing flexibility and distribution efficiency of ...
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