Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted precision medicine strategies.

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

Atara Biotherapeutics Inc (NASDAQ:ATRA) saw its stock jump 7% following the U.S. Food and Drug Administration’s acceptance of ...

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National ...

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has expanded its Retina Scientific Advisory Board (SAB) and executive leadership ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Replimune Group, Inc. ("Replimune or the "Company") (NASDAQ: REPL).

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...