AstraZeneca, FDA and MCL treatment

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,
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 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.
AstraZeneca lymphoma therapy Calquence gets expanded approval in the U.S.
AstraZeneca (AZN) stock in focus as the U.S. FDA expands approval for its lymphoma therapy Calquence with chemoimmunotherapy as a first-line option. Read more here.
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
Harnessing AI and data science to discover life-changing medicines at AstraZeneca
From accelerating drug development and clinical trials to supercharging collaboration, machine learning-enhanced healthcare ...
ジャパンタイムズ22h
AstraZeneca and Daiichi Sankyo win U.S. approval for breast cancer drug
The Food and Drug Administration approved the drug for patients with advanced breast tumors whose cells bear a certain ...
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 ...
BioPharma Dive1d
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.
STAT11d
Johnson & Johnson says its lung cancer drug significantly extended survival
Johnson & Johnson says its bispecific antibody, paired with a Janssen drug, could change treatment for non-small lung cancer ...
FiercePharma1d
Novo's semaglutide among 2nd batch of drugs selected for IRA price negotiations
The U.S. government has selected the second batch of drugs up for Medicare price negotiations under the Inflation Reduction ...
devdiscourse1d
Healthcare Transformations: Navigating Challenges in Drug Pricing and Patient Safety
Current health news highlights include debates over Medicare pricing for drugs like Ozempic and Wegovy, management shifts ...
AstraZeneca overhauls management of its scandal-hit China division
AstraZeneca has overhauled its local management in China in a bid to move on from recent scandals and revive sales after the ...