AstraZeneca, FDA

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 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.
US FDA approves AstraZeneca's drug for breast cancer
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of breast cancer, the health regulator said on Friday. The treatment, jointly developed with the Japanese company,
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 therapy and chemotherapy for unresectable or metastatic disease.
AstraZeneca Gets FDA Approval for Metastatic Breast Cancer Treatment Datroway
AstraZeneca said the U.S. Food and Drug Administration approved Datroway, a treatment for metastatic breast cancer developed in combination with Daiichi Sankyo. The Anglo-Swedish drugmaker on Friday said that the approval is for adult breast cancer patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
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.
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 ...
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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 ...
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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, ...
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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 ...
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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 ...
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Calquence Combo Therapy Approved for Previously Untreated Mantle Cell Lymphoma
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 ...
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.
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 ...
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 ...
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Novo shares high-dose Wegovy results; Amgen, AstraZeneca drugs get expanded OKs
A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter and Boehringer reported a Phase 3 failure.