AstraZeneca, FDA and Calquence

AstraZeneca's Calquence gains FDA nod for 1L MCL treatment
AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $207.67 billion and impressive gross profit margins of 82.61%, announced that its drug Calquence (acalabrutinib),
AstraZeneca’s Calquence granted FDA approval in untreated mantle cell lymphoma
AstraZeneca’s (AZ) Calquence (acalabrutinib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for mantle cell lymphoma (MCL).
AstraZeneca’s Calquence combination approved in U.S.
Calquence in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients
AstraZeneca Gets Full FDA Approval for CMS-Selected Lymphoma Treatment
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.
FDA Approves AstraZeneca's Calquence Combo Therapy For Untreated Mantle Cell Lymphoma
AstraZeneca's Calquence gains FDA approval for untreated mantle cell lymphoma, supported by data showing improved survival and reduced disease progression.
FDA approves AstraZeneca's Calquence for untreated mantle cell lymphoma
Investing.com -- AstraZeneca (LON: AZN) in a stock exchange filing on Friday said that the FDA approved its drug Calquence (acalabrutinib) to treat previously untreated mantle cell lymphoma (MCL) in adults who cannot have a stem cell transplant.
AstraZeneca lymphoma therapy Calquence gets expanded approval in the U.S.
AstraZeneca (NASDAQ:AZN) announced Friday that the U.S. FDA approved its Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) with chemoimmunotherapy as a first-line option for adults with mantle cell lymphoma,
FDA approves new MCL treatment by AstraZeneca
WILMINGTON, Del. - The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca (NASDAQ:AZN)'s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
FiercePharma1d
AstraZeneca's Calquence and Amgen's Lumakras clinch FDA label expansions
Amgen’s Lumakras and AstraZeneca’s Calquence are both in line to expand their respective oncology reaches with new FDA ...
pharmaphorum1d
AZ's Calquence gets first-line OK in mantle cell lymphoma
The new first-line MCL indication gives Calquence a slice of the market of its own and could spur further growth of the drug, ...
Daily11h
USFDA approves AstraZeneca Calquence, bendamustine, rituximab combo for previously untreated mantle cell lymphoma
Cambridge: AstraZeneca has announced that the Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) in ...
EuropaWire5h
AstraZeneca’s Calquence Gains U.S. Approval for First-Line Treatment of Mantle Cell Lymphoma, Following Positive Phase III Results
AstraZeneca's Calquence (acalabrutinib) has been approved by the U.S. FDA for the first-line treatment of adult patients with previously untreate ...
CALQUENCE® (acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma
AstraZeneca’s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma ...
AstraZeneca’s Datroway approved in U.S. for HER2-negative breast cancer patients
DXd, has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-negative breast cancer who have received prior endocrine-based ...