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 ...

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.

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.

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 ...

FDA accepted a new drug application for tirabrutinib in relapsed or refractory PCNSL.

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 ...

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to ...

Approval will broaden the NARCAN® Nasal Spray portfolio, and improve cost-effectiveness byincreasing flexibility and distribution efficiency of ...

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...