U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly ...

Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, ...

NRx Pharmaceuticals (Nasdaq:NRXP) Announces Path to New Drug Application with Real World Data and Broader Proposed Indication for NRX-100 (ketamine) Followin…

NRx together with Osmind, Inc. conducted an in-person meeting attended by leadership of the FDA Division of Psychiatry ...
CURE

FDA Accepts Tirabrutinib Application for Relapsed PCNSL

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

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with 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 ...
Targeted Oncology

FDA Accepts New Drug Application for BTK Inhibitor Tirabrutinib

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 ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

F. Hoffmann-La Roche Ltd: FDA accepts New Drug Application for Roche's giredestrant in ESR1-mutated, ER-positive advanced breast cancer

Filing acceptance based on phase III data showing giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus ...
Seeking Alpha

BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

NEW HAVEN, Conn., Jan. 20, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in ...