The drug received accelerated approval in October 2017 as monotherapy for adults with MCL who have received at least one ...

WASHINGTON - The U.S. Food and Drug Administration has granted approval to AstraZeneca (NASDAQ:AZN)'s Calquence (acalabrutinib), in combination with bendamustine and rituximab, for the treatment of ...

The approval of Calquence marks the first and only BTK inhibitor approved for the first-line treatment of MCL in the US.

The FDA approved two oncology regimens on Jan. 16.One is for a subset of patients with colorectal cancer and the other for ...

Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced the risk ...

The new first-line MCL indication gives Calquence a slice of the market of its own and could spur further growth of the drug, ...

The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the ...

MB-105, a first-in-class CD5-targeted CAR T-cell therapy, received FDA orphan drug designation for relapsed/refractory T-cell ...

The Food and Drug Administration has granted traditional approval to Calquence with bendamustine and Rituxan for some ...

The Food and Drug Administration (FDA) has approved Calquence ® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adults with previously untreated mantle cell ...

Company prepares to advance to Phase 2 clinical trial in early 2025HOUSTON, Jan. 28, 2025 (GLOBE NEWSWIRE) -- March Biosciences (March Bio), an ...

CALQUENCE® (acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma ...