The FDA has accepted the BLA for lecanemab-irmb SC for weekly maintenance dosing in the treatment of early Alzheimer disease.

Shares of Atara Biotherapeutics ATRA plunged 40.5% on Thursday after the FDA issued a complete response letter (CRL) against ...

The FDA has issued a complete response letter to the biologics license application seeking the approval of tabelecleucel for ...

Regenxbio's rolling BLA submission completion of RGX-121 for the treatment of patients with MPS II expected in Q1 of 2025.

The FDA has accepted Eisai and Biogen’s biologics license application for a monthly infusion of IV Leqembi to treat ...

If approved, subcutaneous autoinjector Leqembi will be the only Alzheimer's medication that can be administered at home. The ...

Eisai and Biogen are one step away from deploying a more convenient version of their jointly developed Alzheimer’s treatment ...

Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Biologics ...

Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has accepted Eisai’s Biologics License Application, BLA, for ...

In a pooled analysis from two trials, Dato-DXd has shown promise as a treatment for advanced EGFR-mutated NSCLC.

The National Testing Agency (NTA) has commenced registrations for the Common University Entrance Test for Postgraduate (CUET PG) 2025, with applications open until February 1, 2025. Conducted ...

There were fewer political-themed personal license plate applications in 2024. The Ohio BMV rejected almost 50 political messages in 2021. Last year, it was fewer than 10.