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 ...

Under the agreement, AGC Biologics will manufacture the lentiviral vector used to produce lete-cel, an engineered T-cell ...

Atara Biotherapeutics (ATRA) announced it received a complete response letter from the FDA for the Ebvallo biologics license application as ...

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 ...

The agency expects to issue a decision by Aug. 31, and it is slated to decide on maintenance dosing for an intravenous form of the drug later this month.

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.